Reported Aug 29, 2012 · Terminated
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- Altrx" Altralinked"
- Polyethylene liners DescriptionAn 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
- PackagingProduct 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 UseAn 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
- Lot codes and dates
- Catalog number1221-36-054
- and Lot Number231859
- Amount recalled
- 20 liners
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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