Recall Z-2056-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-2056-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-13

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-04-13, terminated 2019-03-26. It names 2 FDA 510(k) clearances: K091908, K051496. Product: Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin. Reason: Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-13
Terminated: 2019-03-26
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K091908 — M3 MONITORSpectrum Medical , Ltd.·cleared 2009-07-10
K051496 — COBALT BONE CEMENTBiomet, Inc.·cleared 2005-08-04

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

Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin

Reason for recall

Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.

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