FDA-Device2016-12-07Class II
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Synthes (USA) Products LLC
Hazard
Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.
Sold states
Distributed Nationwide
Affected count
84 units
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0681-2017Don't want to check this manually?
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