Recall Z-0625-2016— Zimmer Biomet, Inc.

Name: FDA recall Z-0625-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-17

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2015-11-17, terminated 2016-08-12. It names one FDA 510(k) clearance: K133556. Product: Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952. Reason: Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-17
Terminated: 2016-08-12
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K133556 — VIRAGE OCT SPINAL FIXATION SYSTEMZimmer Spine, Inc.·cleared 2014-06-02

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

Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952

Reason for recall

Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.

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