Data Foundry

Medical device recalls 2014

FMP X-alt Acetabular Liner This acetabular liner is intended for use… — Class II medical device recall Z-1130-2014

Terminated recall by Djo Surgical, reported 2014-03-12, distributed nationwide. Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were

Recall numberZ-1130-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmDjo Surgical, Austin, TX, United States
Recall initiated2014-02-07
Classified2014-03-04
Reported by FDA2014-03-12
Terminated2014-10-01
DistributedNationwide (US)
Reason classeslabeling
Lot numbers728F1089
Serial numbers685F1034
Model numbers931-28-248, 932-36-252

Product

FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.

Reason for recall

Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252, Lot# 728F1089 on the inside (1

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-1130-2014. 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.