U&I Corp. Recalls Velofix SA Cervical Cages Due to Dimensional Defects
U&I Corp. is recalling 42 Velofix SA cervical cages because screw-hole dimensions may be out of range, posing a risk of screw pullout or instability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a structural defect could lead to instability or screw pullout, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
U&I Corp. is recalling 42 units of the Velofix SA cervical cage (REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410). 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: a PEEK cage, a titanium plate, and two titanium markers.
The recall was initiated because the vertical dimensions of the screw-hole position in some standalone cages might be out of range in engineering drawings. This defect creates a possibility of screw pullout, loosening, instability, or less bone-screw engagement than intended by physicians.
The affected lots are A18K220, A18L065, A18L013, A18L014, A18L015, A18L018, A18L019, A18L020, and A18L021. The devices were distributed nationwide in the United States, specifically within the state of California. Healthcare providers and patients should contact U&I Corp. for further instructions regarding the recall.
The recalled product
- Product
- 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 fr
- Manufacturer
- U&I CORP.
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lots: A18K220
- A18L065
- A18L013
- A18L014
- A18L015
- A18L018
- A18L019
- A18L020
- A18L021
Distribution
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