FDA-Device2024-09-04Class II
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Howmedica Osteonics Corp.
Hazard
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Sold states
International distribution to the country of Australia.
Affected count
1 unit (OUS only)
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2732-2024Don't want to check this manually?
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