Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1916-2024 — 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

U.S. FDA — Device Enforcement · United States · 2024-04-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1916-2024
Date of alert
2024-04-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes (USA) Products LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10886982075192
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.