Class II

Medical Device Recall: 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

Synthes (USA) Products LLC · April 25, 2024

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

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

States Affected

NATIONWIDE

Quantity Affected

261 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1916-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.