Synthes (USA) Products LLC: Medical Device Recall in 2022 - (Recall #: Z-0101-2023)

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:

DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

Product Classification:

Class II

Date Initiated: September 27, 2022

Date Posted: October 26, 2022

Recall Number: Z-0101-2023

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: 196

Code Information:

UDI-DI (GTIN): 00810633022047 Lot/Expiry MHC200114 2/9/2026 MHC220117 3/2/2027

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated