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Implants & Prosthetics

ðŸĨ Medical Devices â€Ē 4,589 recalls

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Jun 7, 2013 Implants & Prosthetics View Details →

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Jun 7, 2013 Implants & Prosthetics View Details →

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Jun 7, 2013 Implants & Prosthetics View Details →

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Jun 7, 2013 Implants & Prosthetics View Details →

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Jun 7, 2013 Implants & Prosthetics View Details →

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Jun 7, 2013 Implants & Prosthetics View Details →

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Jun 7, 2013 Implants & Prosthetics View Details →

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Jun 7, 2013 Implants & Prosthetics View Details →

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Jun 7, 2013 Implants & Prosthetics View Details →

Potential for set screw to be come deformed.

May 7, 2013 Implants & Prosthetics Nationwide View Details →

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

May 3, 2013 Implants & Prosthetics Nationwide View Details →

-90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 Electrosurgical cutting and coagulation device and accessories. -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266 -Small Joint ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494, 122663 -StarVac ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey)5.5mm. Ref. ASC 4251-01 Lot 122630, 122593, 122483, 123044, 122283, 122595 -Super MultiVac 50, 50 Degree, w/Suction and Integrated Cable, (Grey/Black) 3.0mm. Ref. ASC 4830-01 Lot 122029, 123044, 122663 -Super TurboVac 90, 90 Degree Suction ArthroWand, (White/Grey) 3.5mm. Ref. ASC 4250-01 Lot 122029,122654, 122651, 122427, 122630, 122494, 122626, 122745, 122293, 122663, 122325, 122765 -TAC-C II Probe, w/Integrated Cable, (Blue/Grey). Ref. 7209628 Lot 122486 -TriStar 50 Suction ArthroWand, 50 Degree w/Integrated Cable, (White/Grey). Ref. ASC 4630-01 Lot 122283 -Turbinate, Tissue Coagulating Electrode, (White). Ref. 1120-4110-01 Lot 122486 -VAPR Hook Electrode W/Integrated Handpiece 3.5mm. Ref. 227305 Lot 122288, 122466 -VAPR LD, Suction Electrode, Large Diameter (Blue) 4.0mm. Ref. 225360 Lot 122512 -VAPR Premiere50-, w/Integrated Cable, Suction, (Black/White) 3.0mm. Ref. 227504 Lot 122029, 122455 -VAPR Premiere90 w/Suction tion, Integrated Cable, (Black/White) 3.3mm. Ref. 227204 Lot 122029, 122446, 122466, 122306, 122435, 122293, -VAPR S90 Suction Electrode, w/Integrated Cable, (Black/White). Ref. 225370 Lot 122577, 122455, 122593, 122288, 122466, 122589, 122356, 122639, 122325, 122318 -VAPR Side Effect Electrode (Blue) 3.5mm. Ref. 225301 Lot 122512 -VAPR Side Effect Electrode, w/Integrated Handpiece 3.5mm. Ref. 227301 Lot 122288, 122356, -VAPR Wedge Electrode (Short,) w/Integrated Cable (Black/White) 2.3mm x 85 mm. Ref. 227213 Lot 122409 -VAPR Wedge Electrode, w/Integrated Cable (Black/White) 2.3mm. Ref. 227203 Lot 122486, 122639 -VAPR Angled, Side Effect Electrode (Blue) 3.5mm. Ref. 225302 Lot 122512 -Vulcan Sa

Surgical Instrument Service And Savings

Class I - Dangerous

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

May 3, 2013 Implants & Prosthetics Nationwide View Details →

- Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm Ref. 7205326 Lot 122609 - BoneCutter Blade, Full Radius, Series 3000 (Orange/Black) 5.5mm Ref. 7206010 Lot 122609 - CoolCut Bone Cutter (Blue/Orange) 3.8mm Ref. AR-8380BC Lot 122631 arthoscope - CoolCut Bone Cutter (Blue/Orange) 4.0mm Ref. AR-8400BC Lot 122631 - CoolCut Bone Cutter (Blue/Orange) 5.5mm Ref. AR-8550BC Lot 122631 - CoolCut Dissector (Blue/Blue) 3.5mm Ref. AR-8350DS Lot 123190 - CoolCut Dissector (Blue/Blue) 4.0mm Ref. AR-8400DS Lot 123190, 122493, 122631 - CoolCut Dissector (Blue/Blue) 5.0mm Ref. AR-8500DS Lot 122493 - CoolCut Dissector Small Joint (Blue/Blue) 3.0mm Ref. AR-7300DS Lot 123190, 122493, 122631, - CoolCut Excalibur (Blue/Beige) 3.8mm Ref. AR-8380EX Lot 122631 - CoolCut Excalibur (Blue/Beige) 4.0mm Ref. AR-8400EX Lot 122631 - CoolCut Oval Burr (12 Flutes) (Blue/White) 5.5mm Ref. AR-8550OBT Lot 122631 - CoolCut Oval Burr (8 Flute) (Blue/White) 4.0mm Ref. AR-8400OBE Lot 122493, 122631, 122279 - CoolCut Oval Burr (8 Flute) (Blue/White) 5.0mm Ref. AR-8500OBE Lot 122493 - CoolCut Round Burr (8 Flute) (Blue/Red) 5.0mm Ref. AR-8500RBE Lot 123190 - CoolCut Sabre (Blue/Green) 3.8mm Ref. AR-8380SR Lot 122493 - DYONICS ELITE Achromobacter (Sage Green) 4.0mm Ref. 72200730 Lot 122665 - Elite* AcromioBlaster Burr (Brick Red/Yellow) 5.5mm Ref. 72200731 Lot 122665 - Formula Aggressive Plus Cutter (Beige/Blue) 5.5mm Ref. 375-564-000 Lot 122309 - Formula Aggressive Plus Cutter (Dk. Blue/Lt. Blue) 5.0mm Ref. 375-554-000 Lot 122490 - Formula Aggressive Plus Cutter (Yellow/Blue) 3.5mm Ref. 375-534-000 Lot 122518, 122309 - Formula Aggressive Plus Cutter Large Hub, (Red/Blue) 4.0mm Ref. 375-544-000 Lot 122594, 122588, 122518, 122278 - Formula Barrel Bur, 12-Flute (Beige/Beige) 5.5mm Ref. 375-951-012 Lot 122278 - Formula Barrel Bur, 12-Flute (Blue/Blue) 5.0mm Ref. 375-951-112 Lot 122594 - Formula Barrel Bur, 12-Flute (Red/Red) 4.0mm Ref. 375-941-012 Lot 122594, 122518 - Formula Barrel Bur, 6-Flute (Beige/Beige) 5.5mm Ref. 375-951-000 Lot 122588 - Formula Barrel Bur, 6-Flute (Red/Red) 4.0mm Ref. 375-941-000 Lot 122588 - Formula Full Radius Cutter, Small Joint, (Grey) 2.5mm Ref. 375-627-000 Lot 122594 - Formula Hooded Abrasion Bur, Small Joint, (Orange) 3.0mm Ref. 375-647-000 Lot 122518 - Formula Resector Cutter (Red/Black) 4.0mm Ref. 375-542-000 Lot 122588 - Formula Resector Cutter (Yellow/Black) 3.5mm Ref. 375-532-000 Lot 122594, 122490, 122588 - Formula Round Bur, 12-Flute (Beige/Beige) 5.5mm Ref. 375-950-012 Lot 122278 - Formula Round Bur, 12-Flute (Red/Red) 4.0mm Ref. 375-940-012 Lot 122594 - Formula Round Bur, 6-Flute (Blue/Blue) 5.0mm Ref. 375-950-100 Lot 122490 - Formula Round Bur, 6-Flute (Red/Red) 4.0mm Ref. 375-940-000 Lot 122518 - Formula Slotted Whisker (Red/Red) 4.0mm Ref. 375-548-000 Lot 122594 - Formula Tomcat Cutter (Red/White) 4.0mm Ref. 375-545-000 Lot 122588 - Formula Tomcat Cutter (Yellow/White) 3.5mm Ref. 375-535-000 Lot 122588 - Full Radius Blade (Yellow) 4.5mm Ref. 7205306 Lot 122347, 122454, 122609, 123270, 122665 - Full Radius Blade, (Beige) 3.5mm Ref. 7205305 Lot 122609, 122665 - Full Radius Blade, (Orange) 5.5mm Ref. 7205307 Lot 122665 - Full Radius ELITE Blade (Beige) 3.5mm Ref. 7210751 Lot 122465, 122665 - Full Radius Mini Blade, 7cm Length (Red) 2.9mm Ref. 3419 Lot 122609 - Full Radius Resector Large Hub, Sterling, Shaver, (Yellow) 4.2mm Ref. 9247A Lot 123263, 122592, 123353 - Full Radius Resector, Large Hub, Merlin, Pre-Bent 15 Degree, (Yellow/Black) 4.2mm Ref. C9241 Lot 123263 - Full Radius Resector, Sterling, Large Hub, (Yellow) 3.5mm Ref. C9248 Lot 123263, 122592, 122511 - Gator B

Surgical Instrument Service And Savings

Class I - Dangerous

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

May 3, 2013 Implants & Prosthetics Nationwide View Details →

The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.

May 24, 2013 Implants & Prosthetics Nationwide View Details →

It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.

May 13, 2013 Implants & Prosthetics Nationwide View Details →

The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.

Jun 3, 2013 Implants & Prosthetics Nationwide View Details →

The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.

Jun 3, 2013 Implants & Prosthetics Nationwide View Details →

Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und

Jun 3, 2013 Implants & Prosthetics View Details →

The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.

Jun 3, 2013 Implants & Prosthetics Nationwide View Details →