Synthes (USA) Products LLC: Medical Device Recall in 2022 - (Recall #: Z-0099-2023)

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:

SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512

Product Classification:

Class II

Date Initiated: September 27, 2022

Date Posted: October 26, 2022

Recall Number: Z-0099-2023

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: 94 US; 30 OUS

Code Information:

UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated