DePuy Orthopaedics, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2220-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 carton, labeled, and shrink-wrapped. Intended Use: 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.

Product Classification:

Class II

Date Initiated: July 24, 2012

Date Posted: August 29, 2012

Recall Number: Z-2220-2012

Event ID: 62649

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.

Status: Terminated

Product Quantity: 20 liners

Code Information:

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

Distribution Pattern:

Worldwide Distribution - USA including PA and the country of Canada

Voluntary or Mandated:

Voluntary: Firm initiated