Z-0625-2016Class II

Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve...

Name: Z-0625-2016 Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve...
Creator: Zimmer Biomet, Inc.
Published: 2015-11-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-11-17 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the... on 2015-11-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0625-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-17
Posted: 2016-01-09
Terminated: 2016-08-12
Recalling firm: Zimmer GmbH
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
Product code: KWP Appliance, Fixation, Spinal Interlaminal
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were sent a Zimmer Biomet "Urgent Medical Device Recall" letter dated November 17, 2015. One letter was addressed to Risk Manager and Surgeons and a separate letter was sent to Distributors, Sales Representatives, and Distributor Operations Mangers. The letters described the problem and the product involved in the recall. The letter described the "Risk" and the responsibilities of consignees and requested consignees to quarantine the product. Risk Managers and Surgeons were requested to complete and return the Certificate of Acknowledgment form. Distributors, Sales Representatives, and Distributor Operations Mangers were requested to complete and return the Inventory Return certification Form. For questions consignees can call the customer call center at 1-866-774-6368 between 8:00 am and 5:00 pm EST.
Quantity in commerce: 372
Distribution: US: AL, AZ, CA, CO, FL, GA, ID, MI, MN, MO, NV, NJ, OK, OR, PA, SD, TN, TX, WA, WI. OUS: AUSTRALIA, GERMANY, SWITZERLAND, SWEDEN.
Product codes and lots: Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0625-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0625-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)