Recall Z-2989-2020— Wright Medical Technology Inc

Name: FDA recall Z-2989-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-26

Class II · Terminated

Class II FDA medical device recall by Wright Medical Technology Inc, initiated 2020-08-26, terminated 2021-04-27. It names 2 FDA 510(k) clearances: K060731, K991915. Product: EVOLVE STEM 8.5MM Model # 496S085. Reason: Lack of sterility assurance.

Recalling firm: Wright Medical Technology Inc
Classification: Class II
Status: Terminated
Initiated: 2020-08-26
Terminated: 2021-04-27
Firm location: Arlington, 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

EVOLVE STEM 8.5MM Model # 496S085

Reason for recall

Lack of sterility assurance

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