U&I Corp Recalls ANAX 5.5 Poly-Reduction Screws Due to Incorrect Laser Etching
U&I Corp. is recalling six ANAX 5.5 Poly-Reduction Screws because they were laser etched with the wrong size (6.0x45 instead of 6.0x50).
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a minor labeling error (incorrect laser etching) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
U&I Corp. is recalling six units of the ANAX 5.5 Poly-Reduction Screw 6.0X50MM (REF: SFNA6050R), which is part of the ANAX 5.5 SPINAL SYSTEM. The recall is due to a labeling error where the screws were laser etched with the dimensions "6.0x45" instead of the correct "6.0x50mm".
The affected units are identified by Lot # 19C12063. The distribution pattern for these specific units is limited to Arizona (AZ) in the United States.
Healthcare providers and patients should stop using these specific screws and contact U&I Corp. for further instructions or replacement. This recall addresses a documentation and labeling discrepancy to ensure the correct product specifications are identified during use.
The recalled product
- Product
- ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
- Manufacturer
- U&I CORP.
- Hazard
- Affected units
- 6
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 (1)
- Lot #: 19C12063
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · U&I CORP.
See all →- HighU&I Corp. Recalls Velofix SA Cervical Cages Due to Dimensional Defects
FDA (Devices) · 2020-05-06
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02