Recall Z-0005-2023— Wright Medical Technology, Inc.

Name: FDA recall Z-0005-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-03

Class II · Ongoing

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2022-08-03. It names 2 FDA 510(k) clearances: K060731, K991915. Product: 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.. Reason: 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..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-03
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

2 on FDA's record

K060731 — EVOLVE MODULAR RADIAL HEADWrightmedicaltechnologyinc·cleared 2006-04-19
K991915 — MODULAR RADIAL HEADWrightmedicaltechnologyinc·cleared 1999-09-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.