Howmedica Osteonics Corp. recalls Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100

Recalled September 4, 2024 · FDA recall Z-2732-2024 · Howmedica Osteonics

Hazard

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

Units

1 unit (OUS only)

Sold at

International distribution to the country of Australia.

Description

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

Product

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

Manufacturer(s)

Howmedica Osteonics Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →