FDAClass IIAugust 29, 2012

Altrx" Altralinked" Polyethylene liners Description: An recall

Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the…

Why was Altrx" Altralinked" Polyethylene liners Description: An recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog number: 1221-36-054 and Lot Number: 231859

Product
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the…
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
20 liners
Distribution
Worldwide Distribution - USA including PA and the country of Canada
Recall date
August 29, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls