Recall Z-1916-2024— Synthes (USA) Products LLC
Class II · Ongoing
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2024-04-25. FDA's recall record names no specific 510(k) clearance for this event. 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. 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.
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-25
- Firm location
- West Chester, PA, United States
Product 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 for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.