Reported May 29, 2013 · Terminated
Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used…
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?
- Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner
- Ref 1221-36-452 Product UsageAn 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
product code1221-36-452lot 187460
- Amount recalled
- 20 liners
Where it was sold
- Nationwide
- VA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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