Food, drugs, devices › DePuy Orthopaedics, Inc.
Device recall: Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip ar
DePuy Orthopaedics, Inc. (Warsaw, IN) initiated this device recall on 24 Jul 2012; FDA lists 1 product record under event 62649, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 30 Apr 2013. Initiation: voluntary: firm initiated. DePuy Orthopaedics, Inc. has 59 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DePuy Orthopaedics, Inc., Warsaw, IN.
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."
Distribution
"Worldwide Distribution - USA including PA and the country of Canada"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2220-2012 | 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… | 20 liners | Class II | Terminated | 29 Aug 2012 |
Context
Other enforcement events for DePuy Orthopaedics, Inc.
All 59 events for DePuy Orthopaedics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA including PA and the country of Canada"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Apr 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.