Synthes (USA) Products LLC: Medical Device Recall in 2022 - (Recall #: Z-0008-2023)

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:

Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

Product Classification:

Class II

Date Initiated: August 30, 2022

Date Posted: October 12, 2022

Recall Number: Z-0008-2023

Event ID: 90842

Reason for Recall:

Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound

Status: Ongoing

Product Quantity: 191 units

Code Information:

UDI-DI: 00810633022047 Lot Numbers: MHC220119, MHC220120 Expiry Date: 1 June 2027

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated