Reported Sep 4, 2024 · Ongoing
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number:…
Howmedica Osteonics Corp.
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: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific)
- Catalog NumberC-MM100434-00
- Lot codes and dates
- Catalog NumberC-MM100434-00
- Lot NumberHX2H9A
- Amount recalled
- 1 unit (OUS only)
Why it was recalled
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
This product could cause temporary or reversible health problems — stop using it.
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