FDA Device recall Z-1916-2024
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic sur…
- FDA Device
- Class II
- ongoing
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic sur… by Synthes Usa Products, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1916-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-25 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
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
Identifiers
| code_info | UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1916-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.