Recall Z-1019-2016— Zimmer Spine, Inc.

Name: FDA recall Z-1019-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-03

Class II · Terminated

Class II FDA medical device recall by Zimmer Spine, Inc., initiated 2016-02-03, terminated 2016-10-11. It names one FDA 510(k) clearance: K133556. Product: Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).. Reason: Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual..

Recalling firm: Zimmer Spine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-03
Terminated: 2016-10-11
Firm location: Minneapolis, MN, 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

Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).

Reason for recall

Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.

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