Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip ar

FDA device recall Z-2220-2012 · posted 2012-08-17 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

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.

Action taken

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 representatives are to return the recalled products through the normal DePuy Returns process, to attention of Returns and marking H12-16 on the outside of the box. Reconciliation forms should be returned to the DePuy Sales Representative or faxed to 574-372-7567. For clinical questions from Surgeons contact DePuy's Scientific Information Office at 1-888-554-2482. For questions regarding recall information call 574-372-7333.

Root cause

Employee error

Status

Terminated

Product code

LPH

Quantity affected

20 liners

Distribution

Worldwide Distribution - USA including PA and the country of Canada

Date initiated

2012-07-24

Date posted

2012-08-17

Date terminated

2013-04-30

Location

Warsaw, IN

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