FDAFDA · Food and drugs·Recall number Z-1366-2013
Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: 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 May 29, 2013 · Recall initiated: March 7, 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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.
- Lot
- product code1221-36-452, lot 187460.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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