Data Foundry

Medical device recalls 2013

Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner — Class II medical device recall Z-1366-2013

Terminated recall by DePuy Orthopaedics, Inc., reported 2013-05-29, distributed nationwide. DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the prod

Recall numberZ-1366-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmDePuy Orthopaedics, Inc., Warsaw, IN, United States
Recall initiated2012-03-07
Classified2013-05-22
Reported by FDA2013-05-29
Terminated2013-05-24
DistributedNationwide (US)
Countries outside the USIE
Quantity20 liners
Reason classeslabeling
Lot numbers187460
Model numbers1221-36-452

Product

Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: 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.

Reason for recall

DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a 36IDX56OD Neutral Liner. Three ( 3 ) complaints were received in January 2012.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1366-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.