45 results
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13ms
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Sources: EU EUDAMED, US FDA
Left Locking Dorsal 1st MTP Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Dorsal 1st MTP Fusion Plate... REF 70-0012-S... LOT W58120".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
Left Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 1st MTP Revision Fusion Plate... REF 70-0018-S... LOT W58121".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
Right Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP Revision Fusion Plate... REF 70-0019-S... LOT W58122".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 2st MTP/MPJ Combo Fusion Plate... REF 70-0036-S... LOT W58123".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
Right Locking 1st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP/MPJ Combo Fusion Plate... REF 70-0037-S... LOT W58148".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015
CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015
CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015
CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.
FDA Recall
Terminated
·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015
MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)
FDA Recall
Terminated
·Orthofix, Inc·Product code HRS·April 6, 2018
Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 18 Gauge. COMMON/USUAL NAME: TP Needle 18 Gauge. CLASSIFICATION NAME: System, Applicator, Radionuclide, Manual. --- The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each.
FDA Recall
Terminated
·Mick Radio Nuclear Instr Inc·Product code IWF·March 30, 2005
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HRS·August 22, 2011
CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
FDA Recall
Terminated
·iCAD, Inc.·Product code LNH·December 9, 2008
CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response.
FDA Recall
Terminated
·iCAD, Inc.·Product code LNH·December 9, 2008
Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
FDA Recall
Terminated
·Siemens Medical Solutions USA Inc.·Product code KPS·April 22, 2016
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Recall
Terminated
·MTI Precision Products LLC.·Product code EFB·May 7, 2012
0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
FDA Recall
Terminated
·MRP, LLC dba AMUSA·Product code NGT·April 27, 2015
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
FDA Recall
Terminated
·MRP, LLC dba AMUSA·Product code NGT·July 2, 2015
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
FDA Recall
Terminated
·MRP, LLC dba AMUSA·Product code NGT·February 9, 2015
Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.
FDA Recall
Terminated
·Osteotech Inc·Product code MBP·April 20, 2012