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Sign in to claim this brandBiomet, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 56 E Bell Dr, WARSAW, IN, 46581
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 1825034
- DUNS Number
- —
Catalogue (471)
Page 7 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Finn Knee Prosthesis | K910877 | FDA 510(k) | Class II | Active |
| Micromax Suture Anchor | K040475 | FDA 510(k) | Class II | Active |
| Lapidus Plate, 3.5mm Inline Fusion Plate, 3.5mm Mtp Plate (left And Right) | K131670 | FDA 510(k) | Class II | Active |
| Fenning Femoral Component | K960303 | FDA 510(k) | Class II | Active |
| Ringloc + Hybrid Acetabular System | K093235 | FDA 510(k) | Class III | Active |
| Rx90 Low Profile Acetabular System | K042989 | FDA 510(k) | Class II | Active |
| Controlled Delivery For Osteoplasty (cdo System) And Graft Preparation System | K072330 | FDA 510(k) | Class II | Active |
| Nelson Resurfacing Head | K983452 | FDA 510(k) | Class II | Active |
| Ziconia Ceramic Mod Head(type I Taper 28/32, +6mm) | K925345 | FDA 510(k) | Class II | Active |
| Integral Co-Cr Femoral Component | K942479 | FDA 510(k) | Class II | Active |
| A-B Acetabular Component | K954417 | FDA 510(k) | Class II | Active |
| Liverpool Radial Head Replacement Device | K012551 | FDA 510(k) | Class II | Active |
| Uhmwpe Surgical Mesh | K894478 | FDA 510(k) | Class II | Active |
| Oss Modular Stems, Oss Diaphyseal Segments | K123501 | FDA 510(k) | Class II | Active |
| Intex Screw | K012798 | FDA 510(k) | Class II | Active |
| Persona Partial Knee System | K161592 | FDA 510(k) | Class II | Active |
| Power Tek Ii | K020761 | FDA 510(k) | Class II | Active |
| Modular Head Bone Screw | K022952 | FDA 510(k) | Class II | Active |
| Plr Splined Revision Stem | K994184 | FDA 510(k) | Class II | Active |
| Taperloc Femoral Stem And Universal Acetabular Com | K921301 | FDA 510(k) | Class II | Active |
| Tri-Polar System | K991990 | FDA 510(k) | Class II | Active |
| Maxim Rpg Ps Femoral Component | K012348 | FDA 510(k) | Class II | Active |
| Volz Total Wrist Prosthesis | K880156 | FDA 510(k) | Class II | Active |
| Hap Bio-Groove Total Hip Prosth (bio-Interfaces) | K912370 | FDA 510(k) | Class II | Active |
| Impact Modular Total Hip System | K000334 | FDA 510(k) | Class II | Active |
| Mallory/Head Lateralized Press-Fit Femoral | K000538 | FDA 510(k) | Class II | Active |
| Traction Weight Bags | K780233 | FDA 510(k) | Class I | Active |
| Cfe Acetabular Cup | K844941 | FDA 510(k) | Class II | Active |
| Perfuse Percutaneous Decompression System | K141762 | FDA 510(k) | Class II | Active |
| Biomet Craniofacial Acrylic Cement | K011399 | FDA 510(k) | Class II | Active |
| Lactosorb Panels And Fasteners | K984390 | FDA 510(k) | Class II | Active |
| Coaxial Applicator System | K091722 | FDA 510(k) | Class II | Active |
| Modification To Bone Mulch Screw System | K993025 | FDA 510(k) | Class II | Active |
| StageOne Knee Cement Spacer Molds | K213287 | FDA 510(k) | Class II | Active |
| Copeland Eas Humeral Resurfacing Heads | K051843 | FDA 510(k) | Class II | Active |
| Biomet Kirschner Wires (K-Wires) | K241014 | FDA 510(k) | Class II | Active |
| StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis | K161273 | FDA 510(k) | Class II | Active |
| Lus Acetabular Component | K830209 | FDA 510(k) | Class II | Active |
| Mallory-Head Total Hip System | K921181 | FDA 510(k) | Class II | Active |
| Patient-Specific Vanguard Femoral Componets | K102125 | FDA 510(k) | Class II | Active |
| Explor Radial Head Plating System | K110201 | FDA 510(k) | Class II | Active |
| Modified Bmp Trochanteric Plates | K993510 | FDA 510(k) | Class II | Active |
| Biomet Biaxial Total Elbow | K980428 | FDA 510(k) | Class II | Active |
| Arcomxl Polyethylene Liners | K042051 | FDA 510(k) | Class II | Active |
| Reach Hip Component | K982367 | FDA 510(k) | Class II | Active |
| Biomet's Minimally Constrained Elbow | K003253 | FDA 510(k) | Class II | Active |
| Modular Arthrodesis Nail | K042409 | FDA 510(k) | Class II | Active |
| Lactosorb Pop Rivet | K981798 | FDA 510(k) | Class II | Active |
| ALLthread Titanium Suture Anchor | K192942 | FDA 510(k) | Class II | Active |
| Repicci Locked Keel Tibial Bearing | K030446 | FDA 510(k) | Class II | 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 |
|---|---|---|---|---|
| Sep 23, 2025 | Z-0212-2026 | — | open, classified | There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop |
| Sep 9, 2025 | Z-2619-2025 | — | open, classified | The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices. |
| Oct 21, 2024 | Z-0477-2025 | — | open, classified | Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention. |
| May 17, 2024 | Z-2179-2024 | — | open, classified | 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention |
| Mar 13, 2024 | Z-1607-2024 | — | open, classified | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. |
| Nov 2, 2023 | Z-0570-2024 | — | open, classified | One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device. |
| Nov 2, 2023 | Z-0569-2024 | — | open, classified | One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device. |
| Oct 9, 2023 | Z-0382-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0386-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0381-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0374-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0370-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0380-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0377-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0373-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0371-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0388-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0378-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0375-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0387-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0385-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0376-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0372-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0379-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0383-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Oct 9, 2023 | Z-0384-2024 | — | open, classified | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Feb 6, 2023 | Z-1284-2023 | — | open, classified | The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner. |
| Dec 29, 2022 | Z-1043-2023 | — | open, classified | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). |
| Dec 29, 2022 | Z-1042-2023 | — | open, classified | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). |
| Dec 15, 2022 | Z-1018-2023 | — | open, classified | Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier |
| Nov 29, 2022 | Z-1036-2023 | — | open, classified | Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement |
| Feb 14, 2022 | Z-0811-2022 | — | terminated | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part. |
| Feb 14, 2022 | Z-0812-2022 | — | terminated | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part. |
| Feb 14, 2022 | Z-0810-2022 | — | terminated | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part. |
| Feb 14, 2022 | Z-0809-2022 | — | terminated | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part. |
| Jan 7, 2022 | Z-0677-2022 | — | terminated | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. |
| Jan 7, 2022 | Z-0673-2022 | — | terminated | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. |
| Jan 7, 2022 | Z-0670-2022 | — | terminated | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. |
| Jan 7, 2022 | Z-0674-2022 | — | terminated | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. |
| Jan 7, 2022 | Z-0675-2022 | — | terminated | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. |
| Jan 7, 2022 | Z-0672-2022 | — | terminated | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. |
| Jan 7, 2022 | Z-0671-2022 | — | terminated | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. |
| Jan 7, 2022 | Z-0676-2022 | — | terminated | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. |
| Jun 2, 2021 | Z-2270-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2268-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2266-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2274-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2265-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2260-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2267-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2271-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2261-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2259-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2264-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2273-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2262-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2275-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2269-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2272-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Z-2263-2021 | — | terminated | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jan 15, 2021 | Z-1131-2021 | — | terminated | Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw. |
| Dec 23, 2020 | Z-0882-2021 | — | terminated | The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill. |
| Dec 1, 2020 | Z-0723-2021 | — | terminated | Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure |
| Nov 25, 2020 | Z-0616-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0619-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0620-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0617-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0631-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0621-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0627-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0624-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0630-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0626-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0625-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0623-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0629-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0618-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0628-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Nov 25, 2020 | Z-0622-2021 | — | terminated | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Sep 4, 2020 | Z-0081-2021 | — | terminated | Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized |
| Sep 4, 2020 | Z-0083-2021 | — | terminated | Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized |
| Sep 4, 2020 | Z-0082-2021 | — | terminated | Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized |
| Sep 4, 2020 | Z-0084-2021 | — | terminated | Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized |
| Sep 3, 2020 | Z-0097-2021 | — | terminated | Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization. |
| Sep 2, 2020 | Z-0093-2021 | — | terminated | Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters |
| May 14, 2020 | Z-2311-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2313-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2312-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2316-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2315-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2322-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2310-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2323-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2317-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2321-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2319-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2324-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2308-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2304-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Z-2320-2020 | — | terminated | Distributed to the field without having completed design history files or design transfer activities |