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Sign in to claim this brandZimmer Biomet
US
Last updated May 23, 2026
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Catalogue (890)
Page 5 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| The Tether™ | 211H7022 | FDA UDI | N | Active |
| Virage® | 07.01763.002 | FDA UDI | Class I | Active |
| Vital Spinal Fixation System | 727M5512 | FDA UDI | Class II | Active |
| Virage® | 07.01784.001 | FDA UDI | Class I | Active |
| Virage® | 07.01764.002 | FDA UDI | Class I | Active |
| Vital Spinal Fixation System | 727M5510 | FDA UDI | Class II | Active |
| Mobi-C Plug & Fit US | MB3574 | FDA UDI | Class III | Active |
| Vitality® | 07.02161.009 | FDA UDI | Class I | Active |
| Vital Spinal Fixation System | 727M5511 | FDA UDI | Class II | Active |
| Vital™ | 730M0003 | FDA UDI | Class I | Active |
| Vital™ Deformity, Degen, Hooks (S114) | 800M0165 | FDA UDI | Class I | Active |
| Vitality® | 07.02161.010 | FDA UDI | Class I | Active |
| Vitality® | 07.02151.002 | FDA UDI | Class I | Active |
| Vital™ | 800M1055 | FDA UDI | Class I | Active |
| Vitality® | 07.02161.002 | FDA UDI | Class I | Active |
| Virage® | 07.01708.017 | FDA UDI | Class II | Active |
| Virage® | 07.01699.001 | FDA UDI | Class II | Active |
| Vital™ | 730M5090 | FDA UDI | Class II | Active |
| Vital™ | 850M3035 | FDA UDI | Class I | Active |
| Virage® | 07.01773.002 | FDA UDI | Class I | Active |
| Vitality® | 07.02152.001 | FDA UDI | Class I | Active |
| Vital MIS - Universal Navigation | 854M5000 | FDA UDI | Class II | Active |
| Mobi-C Plug & Fit US | MB9032R | FDA UDI | Class II | Active |
| Virage® | 07.01693.005 | FDA UDI | Class II | Active |
| Virage® | 07.01708.010 | FDA UDI | Class II | Active |
| Vitality® | 07.02164.009 | FDA UDI | Class I | Active |
| Vital™ Deformity, Degen, Hooks (S114) | 700M0195 | FDA UDI | Class I | Active |
| Lineum® | 14-525053 | FDA UDI | Class II | Active |
| Polaris™ 4.75 Spinal System | 14-587009 | FDA UDI | Class I | Active |
| Vitality® | 07.02162.009 | FDA UDI | Class I | Active |
| The Tether™ | 200H3100 | FDA UDI | Class I | Active |
| Vital™ Deformity, Degen, Hooks (S114) | 700M5020 | FDA UDI | Class I | Active |
| Virage® | 07.01693.004 | FDA UDI | Class II | Active |
| Vital Spinal Fixation System | 727M8512 | FDA UDI | Class II | Active |
| Virage® | 07.01707.038 | FDA UDI | Class II | Active |
| Vitality® | 07.02163.002 | FDA UDI | Class I | Active |
| Virage® | 07.01713.003 | FDA UDI | Class II | Active |
| Virage® | 07.01708.023 | FDA UDI | Class II | Active |
| Mobi-C Plug & Fit US | MB3354 | FDA UDI | Class III | Active |
| The Tether™ | 211H5535 | FDA UDI | N | Active |
| Virage® OCT | 07.01813.003 | FDA UDI | Class I | Active |
| Timberline® MPF | 8600-1400 | FDA UDI | Class I | Active |
| The Tether™ | 211H7050 | FDA UDI | N | Active |
| Vital™ Deformity, Degen, Hooks (S114) | 700M6008 | FDA UDI | Class I | Active |
| Virage® | 07.01710.012 | FDA UDI | Class II | Active |
| Virage™ | 07.01764.003 | FDA UDI | Class I | Active |
| Vital™ Deformity, Degen, Hooks (S114) | 700M6005 | FDA UDI | Class I | Active |
| Virage® | 07.01707.027 | FDA UDI | Class II | Active |
| Virage™ | 07.01756.001 | FDA UDI | Class I | Active |
| Virage® | 07.01795.001 | FDA UDI | Class I | Active |
Related Companies
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FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 20, 2020 | Z-0696-2021 | — | terminated | Device has the potential for fracture during use. |
| Nov 17, 2020 | Z-0570-2021 | — | terminated | Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system. |
| Sep 24, 2020 | Z-0323-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0374-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0394-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0370-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0361-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0366-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0357-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0385-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0340-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0378-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0328-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0327-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0360-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0351-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0359-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0342-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0368-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0348-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0389-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0367-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0384-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0363-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0332-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0365-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0338-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0381-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0373-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0393-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0388-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0356-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0382-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0349-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0352-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0375-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0376-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0358-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0341-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0343-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0347-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0364-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0372-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0387-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0337-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0329-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0354-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0386-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0362-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0335-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0377-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0324-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0369-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0390-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0325-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0326-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0330-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0391-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0333-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0339-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0353-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0346-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0392-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0383-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0344-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0380-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0350-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0395-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0355-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0379-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0331-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0336-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0396-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0345-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0334-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0371-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Sep 24, 2020 | Z-0397-2021 | — | terminated | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. |
| Aug 14, 2020 | Z-0057-2021 | — | terminated | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. |
| May 5, 2020 | Z-2217-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2227-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2214-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2210-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2220-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2230-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2223-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2215-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2233-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2234-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2226-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2229-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2212-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2228-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2231-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2221-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2218-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2224-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2225-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2211-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2219-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |
| May 5, 2020 | Z-2232-2020 | — | terminated | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. |