Recall Z-0625-2016 ยท KWP Appliance, Fixation, Spinal Interlaminal
Zimmer Biomet, Inc.
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
| Date | Nov 17, 2015 |
| Status | Terminated |
| 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. |
| 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 Representative |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM Zimmer Spine, Inc., Jun 2, 2014 |