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Class 2 Device Recall n/a

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Class 2 Device Recall n/a

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Date Initiated by Firm	October 10, 2019
Create Date	November 07, 2019
Recall Status¹	Terminated ³ on May 19, 2020
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 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339 32855090348 32855090351 32855090352 32855090353 32855090354 32855090368 32855090369 32855090375 32855090376 32855090395 32855090396 32855090402 32855090409 32855090414 32855090434 32855090437 32855090439 32855090448 32855090450 32855090465 32855090484 32855090496 32855090497 32855090498 32855090501 32855090507 32855090512 32855090519 32855090520 32855090531 32855090543 32855090576 32855090585 32855090586 32855090593 32855090598 32855090599 32855090609 32855090615 32855090622 32855090628 32855090636 32855090637 32855090638 32855090640 32855090658 32855090659 32855090661 32855090715 32855090734 32855510763 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510808 32855510822 32855510843 32855510844 32855140373 32855411710 32855430479 32855430480 32855430496 32855430498 32855430519 32855430529 32855430533 32855430535 32855430542 32855430544 32855430582 32855430588 32855450430 32855450439 32855450471 32855450483 32855450525 32855470651 32855470715 32855470793 32855470795 32855470796 32855470866 32855470920 32855470921 32855470923 32855480803 32855480808 32855480823 32855480824 32855480828 32855480829 32855480945 32855480963 32855480990 32855481016 32855910440 32855910454 32855910455 32855910456 32855910475 32855910485 32873400307
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.

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