Recall Z-2127-2014— Small Bone Innovations

Name: FDA recall Z-2127-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-19

Class II · Terminated

Class II FDA medical device recall by Small Bone Innovations, initiated 2014-05-19, terminated 2014-10-08. It names one FDA 510(k) clearance: K052576. 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.. 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..

Recalling firm: Small Bone Innovations
Classification: Class II
Status: Terminated
Initiated: 2014-05-19
Terminated: 2014-10-08
Firm location: Morrisville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K052576 — SBI AUTOFIXSmall Bone Innovations, LLC·cleared 2005-11-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.