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Djo Surgical recalls FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with a
Recalled March 12, 2014 · FDA recall Z-1130-2014 · Djo Surgical
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 · FDA Class II
Units
10 units of Model/Catalog Number 931-28-248 Lot/Serial Number(s) 685F1034 labeled asModel/Catalog Number 932-36-252, Lot# 728F1089
Sold at
Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.
Description
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
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.
Manufacturer(s)
Djo Surgical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →