Device product
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
Z-1916-2024
Product summary
- Event
- Event 94546
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 261 units
- Official record key
device-enforcement:Z-1916-2024
Official wording
Reason: 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
Code information: UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
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