Synthes (USA) Products LLC: Medical Device Recall in 2024 - (Recall #: Z-1234-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S

Product Classification:

Class II

Date Initiated: January 24, 2024

Date Posted: March 13, 2024

Recall Number: Z-1234-2024

Event ID: 93924

Reason for Recall:

Products not sterilized, sterility cannot be confirmed

Status: Ongoing

Product Quantity: 5 units

Code Information:

UDI: 10886982087331 Lot Number: 41P2222

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated