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Recall Observatory FDA recall evidence

Device 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

Z-0625-2016

November 17, 2015

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 72832
Status
Terminated
Classification
Class II
Quantity
372
Official record key
device-enforcement:Z-0625-2016

Official wording

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.

Code information: Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869

Distribution pattern: 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.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification