Z-2220-2012Class II

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

Name: Z-2220-2012 Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during...
Creator: DePuy Orthopaedics, Inc.
Published: 2012-07-24
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2012-07-24 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip... on 2012-07-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2220-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-24
Posted: 2012-08-17
Terminated: 2013-04-30
Recalling firm: Depuy Orthopaedics Inc.
Product: 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 code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 20 liners
Distribution: Worldwide Distribution - USA including PA and the country of Canada
Product codes and lots: Catalog number: 1221-36-054 and Lot Number: 231859

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2220-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2220-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-17

Product code LPH

K102423Class IIDepuy Pinnacle Altrx Acetabular LinersDePuy Orthopaedics, Inc. / cleared 2010-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)