FDA-Device2014-08-27Class II
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Synthes, Inc.
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.
Sold states
Distributed in the states of WI and MI.
Affected count
4
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2265-2014Don't want to check this manually?
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