Reported May 6, 2020 · Terminated
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 -…
U&i Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: U&I CORP. · 20 Sandan-Ro 76 Beon-Gil · Uijeongbu-Si Gyeonggi-Do, N/A · N/A
Is this the product you have?
- Velofix SA cervical cage
- REF
TSA161207TSA161208TSA161209TSA161210TSA161407TSA161408TSA161409
- TSA161410 - Product UsageThe 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 componentsPEEK cage, titanium plate, and two titanium markers
- Lot codes and dates
- Lots
A18K220A18L065A18L013A18L014A18L015A18L018A18L019A18L020A18L021
- Lots
- Amount recalled
- 42
Where it was sold
- Nationwide
- CA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new U&i Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.