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U.S. Department of Health and Human Services

Class 2 Device Recall Pinnacle

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  Class 2 Device Recall Pinnacle see related information
Date Initiated by Firm March 07, 2012
Date Posted May 22, 2013
Recall Status1 Terminated 3 on May 24, 2013
Recall Number Z-1366-2013
Recall Event ID 61315
510(K)Number K102423  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452

Product Usage:
An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Code Information product code1221-36-452, lot 187460. 
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
574-267-8143
Manufacturer Reason
for Recall		 DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a 36IDX56OD Neutral Liner. Three ( 3 ) complaints were received in January 2012.
FDA Determined
Cause 2		 Packaging process control
Action DePuy Orthopaedics sent an URGENT INFORMATION- MEDICAL DEVICE RECALL NOTICE dated March 7, 2012 via email to all affected distributors and customers. The letter identified the affected product, problem and actions to be taken. Distributors and customers are instructed to cease further distribution or use or of recalled product and to return them to DePuy. The sales representatives are expected to aid customer in returning of recalled product. Distributors and sales representatives are to return the recalled product through the normal DePuy Returns process. Reconciliation form should be completed and returned to your DePuy Sales Representative or faxed to 574-372-7567. For questions about recall information contact the Manager of Customer Quality 574-372-7333.
Quantity in Commerce 20 liners
Distribution Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.
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 = DEPUY ORTHOPAEDICS, INC.
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