Recall Z-2220-2012 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
DePuy Orthopaedics, Inc.
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
| Date | Aug 17, 2012 (initiated Jul 24, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| Action | Depuy sent an URGENT MEDICAL DEVICE RECALL notification dated July 24, 2012, to all affected consignees. The recall is extended to the Depuy Distributor level and hospital level. All DePuy Distributors were notified via email. The sales representatives notify the hospital either by mail or in person with a written communication. Distributors and customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN. The sales representatives are expected to aid customer in returning of recalled products. Distributors and sales representative |
| Quantity | 20 liners |
| Distribution | Worldwide Distribution - USA including PA and the country of Canada |
| 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 |