FDA-Device2021-06-09Class II
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
Flower Orthopedics Corporation
Hazard
Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
Sold states
US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.
Affected count
47 units
Manufactured in
100 Witmer Rd Ste 280, Horsham, PA, United States
Products
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1698-2021Don't want to check this manually?
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