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.
FDA Recall Z-1823-2020 · Posted None
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Recalling FirmU&I CORP.
Recall StatusTerminated
Product CodeOVE
Date Initiated2019-01-30
Date Terminated2020-11-20
Product Quantity42
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.
Firm Action
On 01/30/2019, "Notification for Sales Suspension and Product recall" and explanation of nonconformity notices were emailed to the domestic customer. The notification requests customers identify, isolate and return affected products immediately. It requests acknowledgement, and quantity of devices to be returned. The contact number for further questions is +82 31 860-6830 or [email protected]
Root Cause
Employee error
Distribution Pattern
US Nationwide distribution in the state of CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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