21 results
·
46ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM, BIOMET MICROFIXATION, 1540 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, 01-736, LOT 999999, QTY 00001, L-SHAPE, 3 X 3 HOLE, 100 DEGREE, LEFT, X-LONG, 0.6 MM, CE 0086.***" Product Usage - CTS Usage: Bone-plate - internal fixation devices intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code JEY·April 26, 2010
The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in part: "***REF 915-3100 LOT***LACTOSORB* SYSTEM HEAT/CONTOURING PEN AND TIPS***QTY 00001***STERILE R STERILE EO***PVC, BRASS***WARNING: DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS. FIRE COULD RESULT.***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA***#915-3100 LOT***QTY 00001, HEAT/CONTOURING PEN AND TIPS***PVC, BRASS***". Product Usage: Two tips are provided with the body of the device to cut / contour the edges of the LactoSorb plates by heating the material.
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code IRQ·November 15, 2011
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code GWO·August 6, 2015
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code GWO·August 6, 2015
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·September 20, 2013
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code KKY·June 13, 2016