Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets Recalled by Small Bone Innovations Due to Small Bone Innovations (SBi) is recalling all lots...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Small Bone Innovations directly.
Affected Products
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 corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.
Quantity: 506
Why Was This Recalled?
Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Small Bone Innovations
Small Bone Innovations has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report