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1,784 recalls
High RiskFDA
Rti Surgical, Inc.
C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devic...
Medical Implants·1,906 affected·Oct 7, 2013
High RiskFDA
Medtronic Vascular, Inc.
Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Gala...
Medical Implants·201 affected·Oct 7, 2013
RecallFDA
Biomet 3i, Llc
ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone fo...
Medical Implants·704 affected·Oct 3, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone ant...
Medical Implants·1 affected·Sep 30, 2013
CriticalFDA
Bard Peripheral Vascular Inc
Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent Sy...
Medical Implants·4,112 affected·Sep 30, 2013
High RiskFDA
Medtronic Neuromodulation
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulati...
Medical Implants·64,163 affected·Sep 30, 2013
High RiskFDA
Orthopediatrics Corp
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instrume...
Medical Implants·7 affected·Sep 26, 2013
High RiskFDA
Spinefrontier, Inc.
Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smo...
Medical Implants·23 affected·Sep 24, 2013
High RiskFDA
Spinefrontier, Inc.
Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4...
Medical Implants·23 affected·Sep 24, 2013
High RiskFDA
Biomet Microfixation, Llc
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) ...
Medical Implants·1 affected·Sep 20, 2013
High RiskFDA
Midmark Corp Dba Progeny Inc
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, includin...
Medical Implants·58 affected·Sep 20, 2013
High RiskFDA
Southern Implants, Inc
Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upp...
Medical Implants·197 affected·Sep 13, 2013
High RiskFDA
Exactech, Inc.
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exacte...
Medical Implants·235 affected·Sep 11, 2013
High RiskFDA
Small Bone Innovations, Inc.
Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Coll...
Medical Implants·2,036 affected·Sep 6, 2013
High RiskFDA
Biomet 3i, Llc
BIOMET 3i Endosseous Dental Implant.
Medical Implants·34,744 affected·Aug 29, 2013
High RiskFDA
Boston Scientific Crm Corp
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models ...
Medical Implants·38,500 affected·Aug 29, 2013
High RiskFDA
Camlog Usa
C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are inten...
Medical Implants·6 affected·Aug 28, 2013
High RiskFDA
Camlog Usa
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental i...
Medical Implants·3 affected·Aug 28, 2013
High RiskFDA
Biomet 3i, Llc
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***Bell...
Medical Implants·10,454 affected·Aug 26, 2013
High RiskFDA
Ge Healthcare It
Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation ...
Medical Implants·28 affected·Aug 26, 2013
High RiskFDA
Medtronic Xomed, Inc.
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Medical Implants·60 affected·Aug 23, 2013
High RiskFDA
Tornier, Inc
AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument se...
Medical Implants·2,298 affected·Aug 13, 2013
High RiskFDA
Microaire Surgical Instruments, Llc
Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled i...
Medical Implants·15,786 affected·Aug 12, 2013
High RiskFDA
Teleflex Medical
Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in ...
Medical Implants·8,220 affected·Aug 8, 2013
High RiskFDA
Atlas Spine, Inc.
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Medical Implants·16 affected·Jul 26, 2013
High RiskFDA
Zimmer, Inc.
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bon...
Medical Implants·1,710 affected·Jul 16, 2013
High RiskFDA
Medtronic Neurosurgery
Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valv...
Medical Implants·915 affected·Jun 28, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5...
Medical Implants·85 affected·Jun 19, 2013
High RiskFDA
Zimmer, Inc.
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item code...
Medical Implants·85 affected·Jun 19, 2013
High RiskFDA
Aesculap, Inc.
ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to a...
Medical Implants·9 affected·Jun 18, 2013
High RiskFDA
Staar Surgical Co.
nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by c...
Medical Implants·3,361 affected·Jun 10, 2013
High RiskFDA
Biomet 3i, Llc
Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower j...
Medical Implants·215 affected·Jun 10, 2013
CriticalFDA
Codman & Shurtleff, Inc.
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) ...
Medical Implants·2 affected·Jun 7, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment,...
Medical Implants·115,722 affected·Jun 3, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, cat...
Medical Implants·115,722 affected·Jun 3, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxi...
Medical Implants·261,109 affected·Jun 3, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump conn...
Medical Implants·115,722 affected·Jun 3, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for bu...
Medical Implants·1 affected·May 29, 2013
High RiskFDA
Codman & Shurtleff, Inc.
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: ...
Medical Implants·431 affected·May 16, 2013
High RiskFDA
Codman & Shurtleff, Inc.
Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Us...
Medical Implants·409 affected·May 16, 2013
High RiskFDA
Codman & Shurtleff, Inc.
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8...
Medical Implants·746 affected·May 16, 2013
High RiskFDA
Codman & Shurtleff, Inc.
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage:...
Medical Implants·369 affected·May 16, 2013
High RiskFDA
Codman & Shurtleff, Inc.
Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS P...
Medical Implants·1,481 affected·May 16, 2013
High RiskFDA
Heartware Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Medical Implants·76 affected·May 16, 2013
High RiskFDA
Codman & Shurtleff, Inc.
Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTA...
Medical Implants·895 affected·May 16, 2013
High RiskFDA
Spine Wave, Inc.
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for int...
Medical Implants·17 affected·May 14, 2013
High RiskFDA
Microgenics Corporation
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corpora...
Medical Implants·188 affected·May 13, 2013
High RiskFDA
Biomet 3i, Llc
Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Medical Implants·33 affected·May 10, 2013