Recall Z-0853-2022— Wright Medical Technology, Inc.

Name: FDA recall Z-0853-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-10

Class II · Terminated

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2022-03-10, terminated 2026-04-01. It names one FDA 510(k) clearance: K203832. Product: EasyFuse Dynamic Compression System Instrument Pack. Reason: The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-03-10
Terminated: 2026-04-01
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K203832 — FuseForce Flex Dynamic Compression SystemWright Medical·cleared 2021-05-07

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

EasyFuse Dynamic Compression System Instrument Pack

Reason for recall

The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.

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