Synthes (USA) Products LLC: Medical Device Recall in 2024 - (Recall #: Z-1916-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 25, 2024

Date Posted: June 5, 2024

Recall Number: Z-1916-2024

Event ID: 94546

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

Status: Ongoing

Product Quantity: 261 units

Code Information:

UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated