FDA-Device2017-01-18Class II
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Trilliant Surgical Ltd.
Hazard
Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
Sold states
Nationwide Distribution
Affected count
50 units
Manufactured in
6721 Portwest Dr Ste 160, Houston, TX, United States
Products
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0960-2017Don't want to check this manually?
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