FDA recall Z-2732-2024

Howmedica Osteonics Corp. · Class II · device

Product

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.

Distribution

International distribution to the country of Australia.

Key facts

Status
Ongoing
Initiation date
2024-08-05
Report date
2024-09-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2732-2024