34 results
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28ms
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Sources: EU EUDAMED, US FDA
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REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
FDA Enforcement
Class II
·Ongoing·Orthofix Srl·June 25, 2025
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.
FDA Enforcement
Class II
·Terminated·Orthofix Srl·June 13, 2018
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
FDA Enforcement
Class II
·Terminated·Orthofix Srl·January 3, 2018
ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019