Reported Apr 8, 2015 · Terminated

RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.

DePuy Orthopaedics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994

Is this the product you have?

  • RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Lot codes and dates
  • CATALOG NO. : 2975-00-920:
  • Barcode (GTIN)10603295156192 Lot No. Distribution SO2018074 (Distributed) SO2018072 (Not Distributed) SO2018073 (Not Distributed) SO2018075 (Not Distributed) SO2018080 (Not Distributed)
Amount recalled
54 of Lot No: SO2018074

Where it was sold

  • Nationwide
  • CA

Why it was recalled

This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 28, 2015 · Data as of Sep 19, 5:30 PM UTC

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