Recall Z-1366-2013 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
DePuy Orthopaedics, Inc.
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.
| Date | May 22, 2013 (initiated Mar 7, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| Action | DePuy Orthopaedics sent an URGENT INFORMATION- MEDICAL DEVICE RECALL NOTICE dated March 7, 2012 via email to all affected distributors and customers. The letter identified the affected product, problem and actions to be taken. Distributors and customers are instructed to cease further distribution or use or of recalled product and to return them to DePuy. The sales representatives are expected to aid customer in returning of recalled product. Distributors and sales representatives are to return the recalled product through the normal DePuy Returns process. Reconciliation form should be c |
| Quantity | 20 liners |
| Distribution | Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102423 | DEPUY PINNACLE ALTRX ACETABULAR LINERS DePuy Orthopaedics, Inc., Oct 29, 2010 |