Date Initiated by Firm | January 03, 2018 |
Create Date | March 09, 2018 |
Recall Status1 |
Terminated 3 on April 11, 2019 |
Recall Number | Z-0939-2018 |
Recall Event ID |
79397 |
510(K)Number | K051491 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
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Product | Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681) |
Code Information |
Part Numbers: 1. 00-7864-013-00, Lot: 63703649; 2. 00-7864-013-20, Lot: 63703681 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
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For Additional Information Contact | 411 Technical Services 574-371-3071 |
Manufacturer Reason for Recall | Two lots of hip implants are mislabeled. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | DISTRIBUTORS: 1. Review this notification and notify affected team members of the contents. 2. Immediately locate and quarantine affected product. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com RISK MANAGERS: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your sales representative will remove the affected product from your facility. 3. Complete Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. |
Quantity in Commerce | 24 |
Distribution | Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland. |
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 = LPH
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