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
Product summary
- 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
out of specification