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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer

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  Class 2 Device Recall Zimmer see related information
Date Initiated by Firm January 11, 2016
Date Posted March 12, 2016
Recall Status1 Terminated 3 on April 13, 2017
Recall Number Z-1145-2016
Recall Event ID 72900
510(K)Number K934765  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Product 47 consists of all product under product code: LPH and same usage:
Item no:
611004022 MODULAR CUP 10 DEGREE LIN
611004428 MODULAR CUP 10 DEGREE LIN
611004628 MODULAR CUP 10 DEGREE LIN
611004828 MODULAR CUP 10 DEGREE LIN
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611005028 MODULAR CUP 10 DEGREE LIN
611005032 MODULAR CUP 10 DEGREE LIN
611005628 MODULAR CUP 10 DEGREE LIN
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611005828 MODULAR CUP 10 DEGREE LIN
611005832 MODULAR CUP 10 DEGREE LIN
611006028 MODULAR CUP 10 DEGREE LIN
611006032 MODULAR CUP 10 DEGREE LIN
611006228 MODULAR CUP 10 DEGREE LIN
611006232 MODULAR CUP 10 DEGREE LIN
611006428 MODULAR CUP 10 DEGREE LIN
611006432 MODULAR CUP 10 DEGREE LIN
611006628 MODULAR CUP 10 DEGREE LIN
611006832 MODULAR CUP 10 DEGREE LIN
611007028 MODULAR CUP 10 DEGREE LIN
612004626 MODULAR CUP 20 DEGREE LIN
612004628 MODULAR CUP 20 DEGREE LIN
612004828 MODULAR CUP 20 DEGREE LIN
612004832 MODULAR CUP 20 DEGREE LIN
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612005032 MODULAR CUP 20 DEGREE LIN
612005628 MODULAR CUP 20 DEGREE LIN
612005828 MODULAR CUP 20 DEGREE LIN
612005832 MODULAR CUP 20 DEGREE LIN
612006028 MODULAR CUP 20 DEGREE LIN
612006032 MODULAR CUP 20 DEGREE LIN
610504428 MODULAR CUP NEUTRAL LINER
610504832 MODULAR CUP NEUTRAL LINER
610505028 MODULAR CUP NEUTRAL LINER
610505032 MODULAR CUP NEUTRAL LINER
610505632 MODULAR CUP NEUTRAL LINER
610505832 MODULAR CUP NEUTRAL LINER
610506032 MODULAR CUP NEUTRAL LINER
610506232 MODULAR CUP NEUTRAL LINER

For use in total hip arthroplasty
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Recalling Firm/
Manufacturer		 Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
For Additional Information Contact Consumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall		 As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
FDA Determined
Cause 2		 Packaging
Action Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
Quantity in Commerce 30
Distribution US Nationwide Distribution
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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