FDAFDA · Food and drugs·Recall number Z-1130-2014
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.
Published March 12, 2014 · Recall initiated: February 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Djo Surgical
- Distributor
- Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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