Recall Z-2593-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-2593-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-28

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-04-28, terminated 2019-05-15. It names one FDA 510(k) clearance: K830196. Product: VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H. Reason: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Terminated: 2019-05-15
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K830196 — CORSTREN COMPRESSION TUBE & PLATEZimmer, Inc.·cleared 1983-03-25

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

VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

Reason for recall

Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

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