—#142323

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

FDA product code: KWP — Appliance, Fixation, Spinal Interlaminal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K133556
Affected lot / code info: Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

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.

Timeline

Recall initiated: 2015-11-17
Terminated: 2016-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142323. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.