Reported Dec 4, 2024 · Ongoing

Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.

Incipio Devices

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: INCIPIO DEVICES · avenue des Paquiers 16 · St-Blaise · N/A

Is this the product you have?

  • Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Lot codes and dates
  • Product Reference No.: 50341105
  • UDI-DI
    • 07630055304735
    • Lot No.: 24A0087
Amount recalled
100 units

Where it was sold

  • Nationwide
  • TN

Why it was recalled

Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.

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

Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.