Z-1823-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- January 30, 2019
- Termination Date
- November 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42
Product Description
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.
Reason for Recall
The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.
Distribution Pattern
US Nationwide distribution in the state of CA.
Code Information
Lots: A18K220, A18L065, A18L013, A18L014, A18L015, A18L018, A18L019, A18L020, A18L021