TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.

Reason: Failure of fusion system instruments in the field.

Code information: Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.

Distribution pattern: US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.