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Recall Observatory FDA recall evidence

Device 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.

Z-1130-2014

February 07, 2014

Class II

Product summary

Firm
Djo Surgical
Event
Event 67468
Status
Terminated
Classification
Class II
Quantity
10 units of Model/Catalog Number 931-28-248 Lot/Serial Number(s) 685F1034 labeled asModel/Catalog Number 932-36-252, Lot# 728F1089
Official record key
device-enforcement:Z-1130-2014

Official wording

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

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

Distribution pattern: Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled