FDA-Device2024-06-05Class II
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
Synthes (USA) Products LLC
Hazard
Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
261 units
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1916-2024Don't want to check this manually?
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