Recall archive / FDA device enforcement
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM... — FDA record Z-2732-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
- Reason
- A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
- Classification
- Class II
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 1 unit (OUS only)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2732-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog Number: C-MM100434-00; Lot Number: HX2H9A; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Australia.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 4, 2024
- Recall initiation date
- Aug 5, 2024
- Center classification date
- Aug 26, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.