STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for… — Class II medical device recall Z-1916-2024
Ongoing recall by Synthes (USA) Products LLC, reported 2024-06-05, distributed nationwide. Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with thei
| Recall number | Z-1916-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2024-04-25 |
| Classified | 2024-05-28 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 261 units |
| UPC / GTIN / UDI-DI | 10886982075192 |
| Lot numbers | 97P6250, 97P6251, 97P6252 |
| Model numbers | 03.130.010 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1916-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.