Small Bone Innovations Recalls AutoFIX Cannulated Compression Screw Systems for IFU Update
Small Bone Innovations is recalling 506 units of 3.0/4.0mm AutoFIX Cannulated Compression Screw Systems to update the Instructions for Use (IFU).
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (updating the IFU) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Small Bone Innovations is recalling all lots of 3.0/4.0mm AutoFIX Cannulated Compression Screw System Sets, Implants, and Instruments. The recall involves 506 units and is being conducted to update the Instructions for Use (IFU).
The affected products are indicated for the treatment of fractures, non-unions, pseudoarthrosis, and degenerative changes, as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones. The recall covers nationwide distribution, including Tennessee, Oklahoma, Arizona, Pennsylvania, Texas, Missouri, New York, North Carolina, California, Florida, Washington, Alabama, Indiana, New Hampshire, South Dakota, and Ohio.
Healthcare providers and patients should contact Small Bone Innovations for further instructions regarding the IFU update. No specific adverse events or injuries are reported in the source text.
The recalled product
- Product
- Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as…
- Manufacturer
- Small Bone Innovations
- Hazard
- Affected units
- 506
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)
- All lots
Distribution
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