Djo Surgical: Medical Device Recall in 2014 - (Recall #: Z-1130-2014)
See the recall detail below. You can also see other recalls from the same firm in 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.
Class II
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
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
Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.
Voluntary: Firm initiated