502 results · 40ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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