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Medtronic Sofamor Danek USA Inc recalls Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF
Recalled May 16, 2018 · FDA recall Z-1641-2018 · Medtronic Sofamor Danek USA
Hazard
The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage. · FDA Class II
Units
231 units
Sold at
US Nationwide Distribution
Description
The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
Product
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
Manufacturer(s)
Medtronic Sofamor Danek USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →