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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012
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Event Detail

Event ID 62649
Product Type Devices
Status Ongoing
Recalling Firm DePuy Orthopaedics, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-24
Initial Firm Notification of
Consignee or Public		 Letter
Distribution Pattern Worldwide Distribution - USA including PA and the country of Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: 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. Catalog number: 1221-36-054 and Lot Number: 231859 Class II In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner. 20 liners Z-2220-2012
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