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Manufacturers
Surgical Instrument Service And Savings, Inc.
Manufacturer Address
Surgical Instrument Service And Savings, Inc., 2747 Sw 6th St, Redmond OR 97756-7109
Manufacturer Parent Company (2017)
Medline Industries Inc.
Source
USFDA
22 Events
Recall of Device Recall CAPSure; Coblator; CoVAC; ArthroWand; Microblastor; Saber; Saphyre; SERFAS; TriStar; VARP; Vulcan.
Recall of Device Recall Instratek Carpal Tunnel Release Blades
Recall of Device Recall ConMed Linvatec Spectrum II and Arthrex SutureLasso
Recall of Device Recall ENDOPATH; Ligaclip MCA; Proximate Plus; and TX Stapler
Recall of Device Recall GII QuickAnchor Plus
Recall of Device Recall Scorpion and SureFire Scorpion
Recall of Device Recall Turbosonics MiniFlared ABS Tip
Recall of Device Recall Barron Radial Vacuum Trephine
Recall of Device Recall ReNew II Endocut Scissor Tip,
Recall of Device Recall Hall MicroChoice
Recall of Device Recall Acorn Bur,
Recall of Device Recall Abrader; AcromioBlaster; CoolCut; Dyonics; Elite; Formula; Gator; Great White; Incisor; RazorCut; Sy
Recall of Device Recall Large Tear Cross Cut Rasp
Recall of Device Recall Midas Rex
Recall of Device Recall IDEAL 30 Suture Grasper (Green) 30 Degree
Recall of Device Recall TPS Micro Reciprocating Small Tear Cross Cut Rasp
Recall of Device Recall SCD Express; VasoForce; Benaflow
Recall of Device Recall Relieva Flex
Recall of Device Recall ACCUPASS; ENDOSCRUB; Spectrum
Recall of Device Recall CLEARTRAC COMPLETE, Threaded Cannula with Obturator
Recall of Device Recall ENDOPATH Resposable Bladeless Trocar, NonHandled, w/Housing,
Recall of Device Recall Harmonic ACE ErgonomicallyEnhanced Curved Shear, Pistol Grip, Hand Controlled,
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22 devices in the database
Device Recall CAPSure; Coblator; CoVAC; ArthroWand; Microblastor; Saber; Saphyre; SERFAS; TriSta...
Model / Serial
122029, 122295, 122486, 122577, 122734, 122654, 123266, 122651, 122427, 122630, 122494, 122595, 122419, 122446, 122308, 122671, 122455, 122593, 122626, 122483, 123044, 122283, 122466, 122673, 122745, 122589, 122306, 122356, 122435, 122502, 122639, 122293, 122663, 122325, 122512, 122765, 122765, 122762, 122409, 122318.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
-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
Device Recall Instratek Carpal Tunnel Release Blades
Model / Serial
122279; 122493; 122504; 122609; 122669; 123190
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 || -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 || -Linvatec CTS Relief Kit. REF 9971, lot 122504 || -Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060. Lot 122504 and Lot 123190. || -KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White). REF 08-0003. Lot # 122609 || Surgical Knife
Device Recall ConMed Linvatec Spectrum II and Arthrex SutureLasso
Model / Serial
122504; 122518; 122504; 122590; 122592; 123190; 123263.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
- ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. || - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. || -- Arthrex SutureLasso SD, 25 Degree Tight Curve Right, w/Nitinol Wire Loop, (Lt. Green) 1.8mm. REF AR-4068-25TR Lot 122518 and Lot 123190. || - Arthrex SutureLasso SD, 90 Degrees (Black) 1.8mm. REF AR-4068-90 Lot 122504. || - Arthrex SutureLasso, 45 Degree, Perforating Needle Cannula, w/Suture Loop, (Lt. Grey). REF AR-4065S Lot 122590. || -SutureLasso, w/Wire Loop, 90 Degree, (Blue) REF AR-4065-90W Lot 123263. || Manual surgical instrument for general use
Device Recall ENDOPATH; Ligaclip MCA; Proximate Plus; and TX Stapler
Model / Serial
122300, 123263, 122490, 122753, 122406, 122675, 122309
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. || -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. || - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W. REF PXW35 Lot 122309 and Lot 123263. || -Proximate Linear Cutter, w/o Staples 75mm. REF TLC75 Lot 122490 || -Ethicon Proximate Plus MD, Skin Stapler Regular. REF PMR35 Lot 122753. || -Proximate Plus, Rotating Head, Skin Stapler (White) Wide. REF PRW35 Lot 122406. || - Ethicon PROXIMATE PLUS, Skin Stapler, Pistol Grip, Fixed Head, Multi-Directional Release, (Grey) Regular. REF PXR35 Lot 122675 and Lot 123263. || -TX Reloadable Linear Stapler 3.5mm Leg, w/o Staples 60mm. Ref. TX60B Lot 122490 || Manual surgical instrument for general use
Device Recall GII QuickAnchor Plus
Model / Serial
123266
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution.
Product Description
GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 || General and Plastic Surgery
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