Custom Made Device - GMRS EXTENSION Piece 40MM LEFT recall
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Why was Custom Made Device - GMRS EXTENSION Piece 40MM LEFT recalled?
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
- Product
- Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 1 unit (OUS only)
- Distribution
- International distribution to the country of Australia.
- Recall date
- September 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)