Synthes (USA) Products LLC: Medical Device Recall in 2022 - (Recall #: Z-0098-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.

Product Classification:

Class II

Date Initiated: September 27, 2022

Date Posted: October 26, 2022

Recall Number: Z-0098-2023

Event ID: 90918

Reason for Recall:

The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

Status: Ongoing

Product Quantity: 81

Code Information:

UDI-DI (GTIN): 00810633020494 Lot MSE210237 Expiry 11/1/2026

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated