Smith & Nephew, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2685-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.

Product Classification:

Class II

Date Initiated: June 24, 2020

Date Posted: July 29, 2020

Recall Number: Z-2685-2020

Event ID: 85920

Reason for Recall:

A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.

Status: Terminated

Product Quantity: 12 units

Code Information:

Model: 71655139 Lot: 19BM13592A

Distribution Pattern:

International distribution in the countries of Brazil, Colombia and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated