FDAFDA · Food and drugs·Recall number Z-2220-2012
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.
Published August 29, 2012 · Recall initiated: July 24, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- Worldwide Distribution - USA including PA and the country of Canada
- Lot
- Catalog number: 1221-36-054 and Lot Number: 231859
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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