FDA Enforcement
Class II
Terminated
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.
Recall: Z-2127-2014
·
Reported August 6, 2014
Enforcement
- Recall Number
- Z-2127-2014
- Event ID
- 68445
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Small Bone Innovations
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 6, 2014
- Initiation Date
- May 19, 2014
- Classification Date
- July 30, 2014
- Termination Date
- October 8, 2014
- Address
- 1380 S Pennsylvania Ave, Morrisville, PA, 19067, United States
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
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 Info
All lots
Distribution
Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH.
Quantity
506