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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 Zimmersee related information
Date Initiated by FirmJanuary 11, 2016
Date PostedMarch 12, 2016
Recall Status1 Terminated 3 on April 13, 2017
Recall NumberZ-1145-2016
Recall Event ID 72900
510(K)NumberK934765 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductProduct 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 611004832 MODULAR CUP 10 DEGREE LIN 611005028 MODULAR CUP 10 DEGREE LIN 611005032 MODULAR CUP 10 DEGREE LIN 611005628 MODULAR CUP 10 DEGREE LIN 611005632 MODULAR CUP 10 DEGREE LIN 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 612005028 MODULAR CUP 20 DEGREE LIN 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 ContactConsumer 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
ActionZimmer 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 Commerce30
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LPH
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