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Recall Observatory FDA recall evidence

Device 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 corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.

Z-2127-2014

May 19, 2014

Class II

Product summary

Firm
Small Bone Innovations
Event
Event 68445
Status
Terminated
Classification
Class II
Quantity
506
Official record key
device-enforcement:Z-2127-2014

Official wording

Reason: 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.

Code information: All lots

Distribution pattern: Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.