Z-1019-2016Class II

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

Name: Z-1019-2016 Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine...
Creator: Zimmer Spine, Inc.
Published: 2016-02-03
License: https://open.fda.gov/license/

Zimmer Spine, Inc. / initiated 2016-02-03 / Terminated

FDA source

Zimmer Spine, Inc. began a recall of Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3) on 2016-02-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1019-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-03
Posted: 2016-02-26
Terminated: 2016-10-11
Recalling firm: Zimmer Spine, Inc.
Product: Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Product code: KWP Appliance, Fixation, Spinal Interlaminal
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.
FDA root cause: Under Investigation by firm
Action: Distributors, Hospital Risk Managers and Surgeons were notified via an Urgent Medical Device Correction letter beginning 2/3/2016. The letter identified affected product, described the issue and listed their responsibilities. A Certificate of Acknowledgement form was asked to be returned to Zimmer Biomet via email to [email protected]. Questions or concerns can be directed to Customer Service at 1-866-774-6368
Quantity in commerce: 15,753
Distribution: Distributed US (nationwide) and in the countries of Australia and Germany.
Product codes and lots: Surgical Technique Manual L1637 Rev B (2014-06)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1019-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1019-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-02-26

Product code KWP

K133556Class IIVirage Oct Spinal Fixation SystemZimmer Spine, Inc. / cleared 2014-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)