| Class 2 Device Recall Trabecular Metal Reverse Shoulder System | |
Date Initiated by Firm | October 10, 2019 |
Create Date | November 07, 2019 |
Recall Status1 |
Terminated 3 on May 19, 2020 |
Recall Number | Z-0299-2020 |
Recall Event ID |
83962 |
510(K)Number | K130661 |
Product Classification |
Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
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Product | Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613
00430900103
00434210613
00434210813
00434210817
00434210913
00434211013
00434211017
00434211113
00434211213
00434211217
00434211313
00434211413
00434211417
00434211513
00434211613
00434211713
00434211813
00434810613
00434810813
00434810817
00434810913
00434811013
00434811017
00434811113
00434811213
00434811217
00434811313
00434811413
00434811417
00434811513
00434811613
00434811713
00434811813
00434900813
00434900817
00434901013
00434901017
00434901213
00434901217
00434901413
00434903700
00434903811
00434903909
00434903912
32855090339
32855090353
32855090368
32855090375
32855090395
32855090512
32855090519
32855090520
32855090531
32855090585
32855090593
32855090598
32855090599
32855090628
32855090636
32855090637
32855090640
32855090658
32855090659
32855090734
47430703100
47430704100
47430706100 |
Code Information |
All product manufactured prior to January 2014. |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
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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 |
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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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510(K) Database | 510(K)s with Product Code = KWT
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