Small Bone Innovations: Medical Device Recall in 2014 - (Recall #: Z-2127-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 19, 2014

Date Posted: August 6, 2014

Recall Number: Z-2127-2014

Event ID: 68445

Reason for Recall:

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.

Status: Terminated

Product Quantity: 506

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.

Voluntary or Mandated:

Voluntary: Firm initiated