Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Reported: September 4, 2024 Initiated: August 5, 2024 #Z-2732-2024
Product Description
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Reason for Recall
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 1 unit (OUS only)
- Distribution
- International distribution to the country of Australia.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;. Recalled by Howmedica Osteonics Corp.. Units affected: 1 unit (OUS only).
Why was this product recalled? ▼
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2024. Severity: Moderate. Recall number: Z-2732-2024.
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