Class II

Medical Device Recall: Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;

Howmedica Osteonics Corp. · August 5, 2024

Reason for Recall

A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.

Distribution

International distribution to the country of Australia.

Quantity Affected

1 unit (OUS only)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2732-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.