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U.S. Department of Health and Human Services

Class 2 Device Recall PERIARTICULAR LKNG PLT TIB ST

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  Class 2 Device Recall PERIARTICULAR LKNG PLT TIB ST see related information
Date Initiated by Firm October 10, 2019
Create Date November 07, 2019
Recall Status1 Terminated 3 on May 19, 2020
Recall Number Z-0309-2020
Recall Event ID 83962
510(K)Number K111039  
Product Classification Plate, fixation, bone - Product Code HRS
Product Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate

Item Nos. 47235700306
47235700308
47235700310
47235700312
47235700314
47235700408
47235700410
47235700412
47235700414
47235700416
47235700504
47235700506
47235700508
47235700510
47235700512
47235700514
47235700518
47235700604
47235700606
47235700608
47235700610
47235700612
47235700614
47235700618
47235700706
47235700708
47235700710
47235700714
47235700808
47235700810
47235700814
47235700906
47235700908
47235700914
47235700918
47235701006
47235701008
47235701010
Code Information All product 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 = HRS and Original Applicant = ZIMMER, INC.
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