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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
- —
- FDA FEI Number
- 1825034
- DUNS Number
- —
Catalogue (471)
Page 5 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TunneLoc Tibial Fixation Device | K193092 | FDA 510(k) | Class II | Active |
| Co-Cr Answer Femoral Component | K931194 | FDA 510(k) | Class II | Active |
| Portable Closed Wound Suction Evacuator | K780848 | FDA 510(k) | Class I | Active |
| Mimix Bone Replacement System | K003494 | FDA 510(k) | Class II | Active |
| Agc Total Knee Prosthesis | K833921 | FDA 510(k) | Class II | Active |
| Cobalt Mv With Gentamicin (aka Cobalt G-Mv) Bone Cement | K092150 | FDA 510(k) | Class II | Active |
| Porous Coated Discovery Elbow | K051975 | FDA 510(k) | Class II | Active |
| Narrow Ascent Interlok Femoral Components | K024037 | FDA 510(k) | Class II | Active |
| Metal On Metal Acetabular System | K993438 | FDA 510(k) | Class III | Active |
| Lactosorb Meniscal Repair Device | K982095 | FDA 510(k) | Class II | Active |
| Spreader Bars | K780226 | FDA 510(k) | Class I | Active |
| Freeman/Samuelson Total Knee System | K943025 | FDA 510(k) | Class II | Active |
| Prosthesis, Knee, Total | K781294 | FDA 510(k) | Class II | Active |
| Ascent All-Poly Ps Tibial Bearings | K021559 | FDA 510(k) | Class II | Active |
| Oncology Salvage System | K002757 | FDA 510(k) | Class II | Active |
| Maxim Knee System | K010027 | FDA 510(k) | Class II | Active |
| Taperloc Complete | K101086 | FDA 510(k) | Class III | Active |
| Biomet Modular Shoulder Prosthesis | K872454 | FDA 510(k) | Class II | Active |
| Bio-Core Interference Screw | K042552 | FDA 510(k) | Class II | Active |
| Vanguard XP Knee System | K153657 | FDA 510(k) | Class II | Active |
| 2.5mm Inline Fusion Plate | K131867 | FDA 510(k) | Class II | Active |
| Sirius Femoral Stem | K130610 | FDA 510(k) | Class II | Active |
| Rx 90 Acetabular Component System | K920639 | FDA 510(k) | Class II | Active |
| Malloy/Head Lateralized Press-Fit Femoral | K003429 | FDA 510(k) | Class II | Active |
| Lactosorb Bone Pin | K953194 | FDA 510(k) | Class II | Active |
| Modular Radial Head Replacement Device | K040611 | FDA 510(k) | Class II | Active |
| Buchalter Fauser Femoral Components | K952686 | FDA 510(k) | Class II | Active |
| Bimetric Total Hip System | K921224 | FDA 510(k) | Class II | Active |
| Endobon | K980679 | FDA 510(k) | Class II | Active |
| Refobacin Bone Cement R | K171540 | FDA 510(k) | Class II | Active |
| Zirconia Ceramic Modular Heads (astro Met) | K943586 | FDA 510(k) | Class II | Active |
| Ascent Xxl Open Box Femoral Component | K002735 | FDA 510(k) | Class II | Active |
| Allthread Peek Anchor With Tantalum Marker | K071569 | FDA 510(k) | Class II | Active |
| Titanium Interference Screws | K193451 | FDA 510(k) | Class II | Active |
| Biomet Concentric Hex Screw | K781389 | FDA 510(k) | Class II | Active |
| Rx90 Femoral Component | K942028 | FDA 510(k) | Class II | Active |
| Resorbable Bone Pins | K011522 | FDA 510(k) | Class II | Active |
| Segmental Distal Femoral Components And Proximal Femoral Bodies With A Compress Female Taper | K080330 | FDA 510(k) | Class II | Active |
| Freedom Constrained Liners | K030047 | FDA 510(k) | Class II | Active |
| Comprehensive Reverse Shoulder-Mini Baseplate | K120121 | FDA 510(k) | Class II | Active |
| Reach Femoral Hip Component | K971824 | FDA 510(k) | Class II | Active |
| Arcos One-piece Femoral Revision System | K151603 | FDA 510(k) | Class II | Active |
| Comprehensive® Reverse Shoulder | K193373 | FDA 510(k) | Class II | Active |
| Orthopedic Salvage System- Oss | K052685 | FDA 510(k) | Class II | Active |
| Vanguard 360 Osseoti Tibial Sleeve Augment | K140883 | FDA 510(k) | Class II | Active |
| Short And Long Soft Tissue Attachment | K022079 | FDA 510(k) | Class II | Active |
| Sirius Femoral Stem, Size 30A | K142295 | FDA 510(k) | Class II | Active |
| Arthrotek Interference Screw | K982497 | FDA 510(k) | Class II | Active |
| Small Hammer Toe Pin | K021828 | FDA 510(k) | Class II | Active |
| Titanium Intramedullary Nails-Various Styles | K982953 | FDA 510(k) | Class II | Active |
Related Companies
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Authorities
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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 |