Z-2127-2014 Class II Terminated
FDA device recall Z-2127-2014 was initiated by Small Bone Innovations on May 19, 2014 and is designated Class II. 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. The recall status is terminated (terminated October 8, 2014). Affected quantity: 506.
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