Z-1130-2014 Class II Terminated
FDA device recall Z-1130-2014 was initiated by Djo Surgical on February 7, 2014 and is designated Class II. 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 p… The recall status is terminated (terminated October 1, 2014). Affected quantity: 10 units of Model/Catalog Number 931-28-248 Lot/Serial Number(s) 685F1034 labeled asModel/Catalog Number 932-36-252, Lot.
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2014
- Initiation Date
- February 7, 2014
- Termination Date
- October 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units of Model/Catalog Number 931-28-248 Lot/Serial Number(s) 685F1034 labeled asModel/Catalog Number 932-36-252, Lot# 728F1089
Product Description
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
Distribution Pattern
Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.
Code Information
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