Recall Z-0325-2020
Zimmer Biomet, Inc. · initiated October 10, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 32855430503 32855430511 32855430526 32855430530 32855430531 32855430536 32855430537 32855430538 32855430539 32855430541 32855430543 32855430546 32855430548 32855430549 32855430550 32855430551 32855430556 32855430557 32855430558 32855430563 32855430565 32855430567 32855430568 32855430569 32855430570 32855430574 32855430575 32855430577 32855450420 32855450441 32855450453 32855450461 32855450499 32855470626 32855470639 32855470641 32855470644 32855470645 32855470648 32855470649 32855470652 32855470653 32855470654 32855470660 32855470663 32855470666 32855470667 32855470669 32855470672 32855470673 32855470679 32855470680 32855470682 32855470683 32855470684 32855470686 32855470688 32855470689 32855470692 32855470693 32855470694 32855470695 32855470698 32855470699 32855470700 32855470701 32855470704 32855470705 32855470706 32855470707 32855470709 32855470710 32855470712 32855470717 32855470719 32855470721 32855470722 32855470725 32855470726 32855470727 32855470728 32855470729 32855470730 32855470732 32855470733 32855470739 32855470741 32855470742 32855470743 32855470744 32855470745 32855470746 32855470749 32855470750 32855470752 32855470753 32855470761 32855470764 32855470765 32855470766 32855470767 32855470768 32855470769 32855470770 32855470771 32855470772 32855470773 32855470774 32855470775 32855470777 32855470778 32855470779 32855470782 32855470783 32855470785 32855470790 32855470791 32855470801 32855470804 32855470805 32855470806 32855470807 32855470808 32855470809 32855470810 32855470811 32855470813 32855470814 32855470815 32855470816 32855470817 32855470818 32855470825 32855470826 32855470831 32855470843 32855470844 32855470851 32855470856 32855470857 32855470858 32855470859 32855470860 32855470861 32855470862 32855470864 32855470867 32855470875 32855470884 32855470885 32855470900 32855470901 32855470902 32855470905 32855470906 32855470907 32855470908 32855470909 32855470910 32855470911 32855470924 32855470929 32855480907 32855480914 32855480918 32855480928 32855480938 32855480955 32855480993 32855480994 32855480996 32855480997
Codes / lots: All products manufactured prior to January 2014.
Reason for recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
FDA-determined cause: Packaging change control
Action taken
The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags. Customers were asked to take the following actions: 1. Review this notification and ensure that pertinent personnel are aware of the contents. 2. Ensure that backup devices for the affected products are available, as per standard orthopedic procedure planning, to reduce the likelihood of an extension of surgery time. 3. Examine devices thoroughly for adherent LDPE bag residue prior to use. Use a backup device if LDPE bag residue is detected. 4. Return any devices which display adherent LDPE bag residue to Zimmer Biomet, consistent with the standard instructions for use regarding the disposition of damaged components. 5. Complete the Certificate of Acknowledgement and return to the firm. 6. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility's documentation. If you have further questions or concerns regarding this recall, please call the firm's customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Details
- Recall number
- Z-0325-2020
- Initiated
- October 10, 2019
- Terminated
- May 19, 2020
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 5,459,583 total devices
- Distribution
- Distributed nationwide.
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0298-2020 Class II | BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0299-2020 Class II | Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0300-2020 Class II | Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0301-2020 Class II | Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0302-2020 Class II | Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0303-2020 Class II | NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos.…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0304-2020 Class II | NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0305-2020 Class II | ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0306-2020 Class II | TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0307-2020 Class II | Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0308-2020 Class II | PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0309-2020 Class II | Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0310-2020 Class II | DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0311-2020 Class II | SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0312-2020 Class II | Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0313-2020 Class II | PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0314-2020 Class II | Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0315-2020 Class II | PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0316-2020 Class II | PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0317-2020 Class II | Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0318-2020 Class II | Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0319-2020 Class II | CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0320-2020 Class II | Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0321-2020 Class II | Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0322-2020 Class II | Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0323-2020 Class II | Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0324-2020 Class II | LPS-MOB ART SURF IMPL D 9MMNon-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0326-2020 Class II | Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0327-2020 Class II | CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0328-2020 Class II | Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |