502 results
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42ms
·
Sources: EU EUDAMED, US FDA
EIGHT-PLATE GUIDED GROWTH SYSTEM SCREW, 24MM
FDA Adverse Event
Malfunction
·ORTHOFIX INC.·Product code HWC·April 20, 2009
XCALIBER OSTEOTITE BONE SCREWS
FDA Adverse Event
Other
·ORTHOFIX SRL·Product code HWC·September 22, 2009
LAG SCREWDRIVER RETENTION ROD
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code HSB·April 11, 2018
EXTERNAL BONE GROWTH STIMULATOR
FDA Adverse Event
Malfunction
·ORTHOFIX INC.·Product code LOF·May 15, 2007
CERVICAL STIM CERVICAL FUSION SYSTEM
FDA Adverse Event
Malfunction
·ORTHOFIX INC.·Product code LOF·March 27, 2007
MODULAR 5/8 RING, 200MM, TL-HEX
FDA Adverse Event
Malfunction
·ORTHOFIX SRL·Product code KTT·February 9, 2017
CABLE
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code JDX·May 2, 2019
ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body tabs from splaying (spreading apart). The Anti-Splay Cap is subsequently removed from the Screw Body after assembly of the construct. The Anti-Splay Cap is a stainless steel machined instrument. The instrument is used within the Firebird Reduction Kit (Domestic, 44-9050) and the ICON Reduction Kit (International, 68-0010). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II.
FDA Recall
Terminated
·Orthofix Inc·Product code NKB·October 22, 2010
Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and universal cap. Cannula is available as an 8 gauge needle or 11 gauge needle.
FDA Recall
Terminated
·Orthofix Inc·Product code LWE·October 18, 2010
Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (Catalog Number: 50-1016), distributed by Orthofix, Inc., McKinney, TX 75069.
FDA Recall
Terminated
·Orthofix, Inc·Product code LXT·September 28, 2007
CONSTRUX MINI PEEK VBR SYSTEM
FDA Adverse Event
Malfunction
·ORTHOFIX INC·Product code MQP·November 29, 2016
FORZA IMPLANT INSERTER
FDA Adverse Event
Malfunction
·ORTHOFIX INC·Product code MDM·December 16, 2016
PHOENIX MIS
FDA Adverse Event
Malfunction
·ORTHOFIX INC.·Product code NKB·August 17, 2015
CENTURION POCT SYSTEM
FDA Adverse Event
Malfunction
·ORTHOFIX INC·Product code KWP·August 28, 2015
INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR
FDA Adverse Event
Injury
·ORTHOFIX INC.·Product code HSB·July 16, 2015
CONSTRUX - PEEK VBR
FDA Adverse Event
Malfunction
·ORTHOFIX INC·Product code MQP·August 5, 2015
SPINE FIXATION SYSTEM
FDA Adverse Event
Malfunction
·ORTHOFIX INC·Product code MNI·September 30, 2015
SFS II PARALLEL ROD CONNECTORS
FDA Adverse Event
Malfunction
·ORTHOFIX INC.·Product code MNI·February 1, 2012
TRUELOK RING FIXATION SYSTEM
FDA Adverse Event
Malfunction
·ORTHOFIX INC.·Product code LXT·January 26, 2012
INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR
FDA Adverse Event
Malfunction
·ORTHOFIX INC.·Product code HSB·February 18, 2012