Device Recall FMP Xalt Acetabular Liner

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Djo Surgical, 9800 Metric Blvd, Austin TX 78758-5445
  • Source
    USFDA