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Synthes, Inc. recalls Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Recalled August 27, 2014 · FDA recall Z-2265-2014 · Synthes
Hazard
A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic. · FDA Class II
Units
4
Sold at
Distributed in the states of WI and MI.
Description
A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
Product
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Manufacturer(s)
Synthes, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →