93 results
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78ms
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Sources: EU EUDAMED, US FDA
Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWC·March 23, 2010
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.
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWC·January 29, 2010
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.
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWC·January 29, 2010
EDGELOCK PLATING SYSTEM
FDA Adverse Event
Other
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HRS·February 22, 2012
MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HWC·May 7, 2014
MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS INC.·Product code HWC·May 7, 2014
MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HWC·May 7, 2014
MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HWC·May 7, 2014
MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HWC·May 7, 2014
MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HWC·May 7, 2014
MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HWC·May 7, 2014
MINI MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS INC·Product code LXH·April 17, 2014
MINI MAXLOCK EXTREME K-WIRE 0.9MM
FDA Adverse Event
Malfunction
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HRS·November 3, 2014
CANNULINK IFS 1.1MM GUIDE WIRE
FDA Adverse Event
Malfunction
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code DQX·November 20, 2014
ORTHOHELIX DRILL BIT
FDA Adverse Event
Malfunction
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HTW·November 26, 2014
MAXLOCK
FDA Adverse Event
Malfunction
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HTW·May 15, 2007
CALCLOCK
FDA Adverse Event
Malfunction
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code KTT·November 12, 2008
MINI MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code LXH·March 5, 2013
MINI MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code HWC·January 14, 2013
MINI MAXLOCK EXTREME
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code LXH·March 5, 2013