Osteomed, LLC FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, SterileClass IIMay 31, 2023Screws for osteotomies have contain an undersize screwhead w	Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate h	Class IIDevices	May 31, 2023
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, SterileClass IIMay 31, 2023Screws for osteotomies have contain an undersize screwhead w	Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate h	Class IIDevices	May 31, 2023
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control CoClass IIOct 28, 2021Due to consoles not in compliance with the latest electrical	Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocke	Class IIDevices	Oct 28, 2021