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U.S. Department of Health and Human Services

Class 2 Device Recall n/a

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  Class 2 Device Recall n/a see related information
Date Initiated by Firm October 10, 2019
Create Date November 07, 2019
Recall Status1 Open3, Classified
Recall Number Z-0302-2020
Recall Event ID 83962
Product Classification Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
Product Various Custom Devices, Item Nos. 32855090246
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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