Howmedica Osteonics Corp. recalls Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM10…

Recall date

August 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2732-2024

FDA classification

Class II

Brand / firm

Howmedica Osteonics Corp.

Sold / distributed

International distribution to the country of Australia.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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