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U.S. Department of Health and Human Services

Class 2 Device Recall Trabecular Metal Primary Hip Prosthesis

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  Class 2 Device Recall Trabecular Metal Primary Hip Prosthesis see related information
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
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
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
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 = LPH and Original Applicant = ZIMMER, INC.
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