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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 61315
Product Type Devices
Status Completed
Recalling Firm DePuy Orthopaedics, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-07
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. product code1221-36-452, lot 187460. Class II 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. 20 liners Z-1366-2013