80 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code DZL·May 31, 2013
BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZL·October 6, 2009
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code DZL·January 11, 2013
BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM. Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code DZL·March 17, 2010
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code DZL·January 11, 2013
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code DZL·January 11, 2013
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code DZL·February 23, 2016
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code DZL·February 23, 2016
DAL-RO Abutment Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
DAL-RO Threaded Female Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·July 23, 2014
DAL-RO Housing, Female Assembly Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·July 23, 2014
Vl DBL OFFST WI LRG STPL, RT Nonsterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·July 23, 2014
VI DBL OFFST W/ LRG STPL, LT Nonsterile
FDA Recall
Terminated
·Zimmer, Inc.·Product code LXH·July 23, 2014
DAL-RO Threaded Female Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
DAL-RO Housing, Female Assembly Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
DAL-RO Abutment Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 20, 2014
VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 20, 2014