Synthes (USA) Products LLC: Device Recall

Recall Details

Recall Number

Z-1916-2024

Classification

Class II

Product Type

Device

Recalling Firm

Synthes (USA) Products LLC

Status

Ongoing

Date Initiated

04/25/2024

Location

West Chester, PA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

261 units

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

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

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Other Recalls by Synthes (USA) Products LLC

• Class II: Risk 09/26/2025
  Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
• Class II: Risk 09/26/2025
  Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

View all recalls by Synthes (USA) Products LLC →