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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