Orthohelix Surgical Designs

4 recalls •

🏥 Medical Devices

• Categories: Implants & Prosthetics, Other Medical Devices, Infusion Pumps

MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.

Class I - Dangerous

Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer

Sep 19, 2014 Implants & Prosthetics View Details →

Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.

Class I - Dangerous

The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.

Oct 30, 2012 Other Medical Devices Nationwide View Details →

OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Class I - Dangerous

The tips of the drivers are breaking while being used to drive the screws into patients.

Jan 29, 2010 Infusion Pumps Nationwide View Details →

OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Class I - Dangerous

The tips of the drivers are breaking while being used to drive the screws into patients.

Jan 29, 2010 Infusion Pumps Nationwide View Details →