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Orthohelix Surgical Designs Recalls
4 recalls on record · October 17, 2012 to October 15, 2014 · Medical Devices
Recalls by year
12
13
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 15, 2014Medical DevicesFDA
Orthohelix Surgical Designs Inc recalls MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside.
Hazard: Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
April 3, 2013Medical DevicesFDA
Orthohelix Surgical Designs Inc recalls Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fix
Hazard: 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.
October 17, 2012Medical DevicesFDA
Orthohelix Surgical Designs Inc recalls OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws
Hazard: The tips of the drivers are breaking while being used to drive the screws into patients.
October 17, 2012Medical DevicesFDA
Orthohelix Surgical Designs Inc recalls OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws
Hazard: The tips of the drivers are breaking while being used to drive the screws into patients.