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).
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 2/5 (Moderate).
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:
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