Wright Medical Technology, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0005-2023)

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:

stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

Product Classification:

Class II

Date Initiated: August 3, 2022
Date Posted: October 12, 2022
Recall Number: Z-0005-2023
Event ID: 90772
Reason for Recall:

The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.

Status: Ongoing
Product Quantity: 16 units
Code Information:

UDI/DI: (01)00840420185877(11)210107(17)290105 Lot Number 1704691

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated