Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-2220-2012 |
| Classification | Class II |
| Code Info | Catalog number: 1221-36-054 and Lot Number: 231859 |
| Product Distributed Qty | 20 liners |
| Reason For Recall | 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. |
Event Detail
| Event Id | 62649 |
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| 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 |
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