Atlas Spine Recalls | RecallPedia

Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

Class I - Dangerous

The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

Jul 26, 2013 Implants & Prosthetics Nationwide View Details →

Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEMModular ScrewdriverAtlas Spine, Inc.www.AtlasSpine.com 1555 Jupiter Park Drive #4Jupiter, Florida 33458561-741-1108Tissue SleeveMFG Date: XX/XX/XXXXLot #: XXXXWeldmentMFG Date: 03/23/2009Sleeve AssemblyMFG Date: XX/XX/XXXXLot #: XXXXQty: 1 Rx OnlyNon-Sterile. Sterilize Prior to Use* Rev. A*. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System.

Class I - Dangerous

Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery.

Jun 4, 2009 Implants & Prosthetics View Details →