Home / Recalls / Small Bone Innovations / Z-2127-2014

Z-2127-2014 Class II Terminated

Recalled by Small Bone Innovations — Morrisville, PA

Recall Details

Product Type: Devices
Report Date: August 6, 2014
Initiation Date: May 19, 2014
Termination Date: October 8, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 506

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.

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.

Distribution Pattern

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

Code Information

All lots