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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer M/L Taper Hip Prosthesis, 7711 Series

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  Class 2 Device Recall Zimmer M/L Taper Hip Prosthesis, 7711 Series see related information
Date Initiated by Firm March 01, 2018
Date Posted March 14, 2018
Recall Status1 Open3, Classified
Recall Number Z-1192-2018
Recall Event ID 79406
510(K)Number K060040  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
Product Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
Code Information Lot Number: 63716613, UDI: (01)00889024131606(17)270731(10)63716613; Lot Number: 63716614, UDI: (01)00889024131606(17)279731(10)63716614
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
Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
FDA Determined
Cause 2
Labeling mix-ups
Action RISK MANAGER: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. DISTRIBUTOR: 1. Review this notification and notify affected team members of the contents. 2. Quarantine affected product in your inventory. 3. Return affected product from your distributorship and from affected hospitals. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 24
Distribution Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
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.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ZIMMER, INC.
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