Reported Mar 15, 2023 · Ongoing

Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

Stryker Leibinger GmbH & Co. KG

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: Stryker Leibinger GmbH & Co. KG · Botzinger Str. 41 · Freiburg Im Breisgau · N/A

Is this the product you have?

  • Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Lot codes and dates
  • TMJ Reconstruction Prosthesis, Catalog #2208151054
  • Lot Number W67725 UDI/DIB004YYMMDDNNNNLM0
Amount recalled
1 unit

Where it was sold

Why it was recalled

Device was shipped without having regulatory approval.

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, 5:40 PM UTC

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