Recall Z-1101-2020— Wright Medical Technology, Inc.

Name: FDA recall Z-1101-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-27

Class II · Terminated

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2019-12-27, terminated 2021-07-23. It names one FDA 510(k) clearance: K060731. Product: WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220. Reason: Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-27
Terminated: 2021-07-23
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K060731 — EVOLVE MODULAR RADIAL HEADWrightmedicaltechnologyinc·cleared 2006-04-19

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

WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220

Reason for recall

Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.

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