FDA Enforcement
Class II
Ongoing
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
Recall: Z-1916-2024
·
Reported June 5, 2024
Enforcement
- Recall Number
- Z-1916-2024
- Event ID
- 94546
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Synthes (USA) Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 5, 2024
- Initiation Date
- April 25, 2024
- Classification Date
- May 28, 2024
- Address
- 1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States
Description
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
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 Info
UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Quantity
261 units