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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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
Related recalls
Same manufacturer · U&I CORP.
See all →- ModerateU&I Corp Recalls ANAX 5.5 Poly-Reduction Screws Due to Incorrect Laser Etching
FDA (Devices) · 2020-07-29
Same hazard · screw pullout
See all →- HighStryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues
FDA (Devices) · 2020-02-19
Other medical device recalls
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateDRG Sperm Ab ELISA Recalled for Potential False Negative Results
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateCervical intervertebral fusion devices recalled for packaging defect
FDA (Devices) · 2023-08-30
- HighMedtronic Catalyft LS Spinal Implant Recall for Out-of-Spec Geometry
FDA (Devices) · 2023-07-19
- HighMedtronic Catalyft LS spinal implant recalled for out-of-specification device dimensions
FDA (Devices) · 2023-07-19
- HighMedicrea IMPIX MANTA+ Cervical Fusion Devices Recalled for Packaging Defect
FDA (Devices) · 2023-08-30
- ModerateSpineFrontier Recalls Indus Invue Screw Caddies Due to Removal Difficulty
FDA (Devices) · 2013-08-14
- ModerateDePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws
FDA (Devices) · 2016-11-30