FDA Device recall Z-1130-2014
FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems
- FDA Device
- Class II
- terminated
- Published 2014-03-12
On 2014-03-12 the FDA classified a Class II recall of FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems by Djo Surgical, citing 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 sterilizatio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1130-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-07 |
| Published | 2014-03-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Djo Surgical |
| Distribution | US |
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
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
Identifiers
| code_info | Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner) were mistakenly packag…Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner) were mistakenly packaged/labeled as Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner) and vice-versa |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1130-2014%22
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