| Class 2 Device Recall NexGen, Zimmer Segmental System, Continuum Knee, Natural Knee | |
Date Initiated by Firm | October 10, 2019 |
Create Date | November 07, 2019 |
Recall Status1 |
Terminated 3 on May 19, 2020 |
Recall Number | Z-0325-2020 |
Recall Event ID |
83962 |
510(K)Number | K120990 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
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 |
Code Information |
All products manufactured prior to January 2014. |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
|
For Additional Information Contact | Zimmer Biomet Customer Service 574-371-3071 |
Manufacturer Reason for Recall | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
FDA Determined Cause 2 | Packaging change control |
Action | 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. |
Quantity in Commerce | 5,459,583 total devices |
Distribution | Distributed nationwide. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JWH
|
|
|
|