FDA Enforcement
Class II
Ongoing
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Recall: Z-2732-2024
·
Reported September 4, 2024
Enforcement
- Recall Number
- Z-2732-2024
- Event ID
- 95114
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 4, 2024
- Initiation Date
- August 5, 2024
- Classification Date
- August 26, 2024
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006, United States
Description
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.
Code Info
Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
Distribution
International distribution to the country of Australia.
Quantity
1 unit (OUS only)