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Manufacturers
Surgical Instrument Service And Savings, Inc.
제조사 주소
Surgical Instrument Service And Savings, Inc., 2747 Sw 6th St, Redmond OR 97756-7109
제조사 모회사 (2017)
Medline Industries Inc.
Source
USFDA
22 Events
Device Recall Harmonic ACE ErgonomicallyEnhanced Curved Shear, Pistol Grip, Hand Controlled, 의 리콜
Device Recall ENDOPATH Resposable Bladeless Trocar, NonHandled, w/Housing, 의 리콜
Device Recall Turbosonics MiniFlared ABS Tip 의 리콜
Device Recall CLEARTRAC COMPLETE, Threaded Cannula with Obturator 의 리콜
Device Recall ACCUPASS; ENDOSCRUB; Spectrum 의 리콜
Device Recall Relieva Flex 의 리콜
Device Recall SCD Express; VasoForce; Benaflow 의 리콜
Device Recall TPS Micro Reciprocating Small Tear Cross Cut Rasp 의 리콜
Device Recall IDEAL 30 Suture Grasper (Green) 30 Degree 의 리콜
Device Recall Midas Rex 의 리콜
Device Recall Large Tear Cross Cut Rasp 의 리콜
Device Recall Abrader; AcromioBlaster; CoolCut; Dyonics; Elite; Formula; Gator; Great White; Incisor; RazorCut; Sy 의 리콜
Device Recall Barron Radial Vacuum Trephine 의 리콜
Device Recall Acorn Bur, 의 리콜
Device Recall Hall MicroChoice 의 리콜
Device Recall ReNew II Endocut Scissor Tip, 의 리콜
Device Recall CAPSure; Coblator; CoVAC; ArthroWand; Microblastor; Saber; Saphyre; SERFAS; TriStar; VARP; Vulcan. 의 리콜
Device Recall Scorpion and SureFire Scorpion 의 리콜
Device Recall GII QuickAnchor Plus 의 리콜
Device Recall ENDOPATH; Ligaclip MCA; Proximate Plus; and TX Stapler 의 리콜
Device Recall ConMed Linvatec Spectrum II and Arthrex SutureLasso 의 리콜
Device Recall Instratek Carpal Tunnel Release Blades 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 22 건
Device Recall Harmonic ACE ErgonomicallyEnhanced Curved Shear, Pistol Grip, Hand Controlled,
모델명 / 제조번호(시리얼번호)
122295, 122308, 122762.
의료기기 분류등급
General and Plastic Surgery Devices
의료기기 등급
Unclassified
이식된 장치?
No
유통
Nationwide Distribution.
제품 설명
Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 || Unclassified
Device Recall ENDOPATH Resposable Bladeless Trocar, NonHandled, w/Housing,
모델명 / 제조번호(시리얼번호)
122338, 122347, 122454, 122592, 123372, 122490, 122490, 123254, 122609, 122429, 123215, 122647, 122300.
의료기기 분류등급
Gastroenterology-Urology Devices
의료기기 등급
2
이식된 장치?
No
유통
Nationwide Distribution.
제품 설명
- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 || - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 || - ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing, 100mm, (Orange) 5mm Ref. 35LDA Lot 122647 || - ENDOPATH Resposable Trocar, Dilating Tip w/Housing, 100mm, (Purple) 10/12mm Ref. 512DA Lot 123215 || - ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215, 122647 || Endoscope and accessories || - ENDOPATH Trocar, Disposable Sleeve Housing, (Green) 10/11mm Ref. 511HR Lot 122647 || - ENDOPATH Blunt Tip Obturator & Housing, w/Olive Plug, 100mm, (Purple) 10/12mm Ref. 512BA Lot 122647 || - ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing, 100mm, (Green) 10/11mm Ref. 511DA Lot 122454, 122647 || - ENDOPATH, Bladeless Trocar with Stability Sleeve, Non-handled 10/12mm Ref. 512NT Lot 123254 || - ENDOPATH Xcel Bladeless Trocar, Handled, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. 811LTH Lot 122300 || - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300 || - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429 || - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. B11LT Lot 122454, 123254, 122429 || - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 100mm Length 5.0mm Ref. B5LT Lot 122347, 122454, 122592, 122490, 123254, 122429, 122300 || - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 75mm Length, (Teal) 5.0mm Ref. B5ST Lot 123254 || - ENDOPATH Xcel Blunt Tip Trocar, w/Smooth Sleeve & Adjustable Plug, (Purple) 12mm x 100mm Ref. H12LP Lot 122338, 122372, 123254, 123215 || - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 11mm x 100mm Ref. D11LT Lot 122454 || - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 12mm x 100mm Ref. D12LT Lot 122454 || - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 5.0mm x 100mm Ref. D5LT Lot 122338, 122454, 122490, 122429 || - ENDOPATH Xcel Integrated Stability Trocar Sleeve 11mm x 100mm Ref. CB11LT Lot 122429 || - ENDOPATH Xcel Integrated Stability Trocar Sleeve 12mm x 100mm Ref. CB12LT Lot 122490 || - ENDOPATH Xcel Integrated Stability Trocar Sleeve 5.0mm x 100mm Ref. CB5LT Lot 122490, 122429, 122300 || - Kii Optical Access System Threaded (Blue) 5mm x 100mm Ref. C0Q04 Lot 122609
Device Recall Turbosonics MiniFlared ABS Tip
모델명 / 제조번호(시리얼번호)
122590, 123372, 123215, 122309.
의료기기 분류등급
Ophthalmic Devices
의료기기 등급
2
이식된 장치?
No
유통
Nationwide Distribution.
제품 설명
- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 || - TurboSonics¿ Mini-Flared ABS¿ Tip, 20 Degree Tip Angle, 45¿ Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 || - TurboSonics¿ Tapered ABS¿ MicroTip" 30¿ Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 || Series 20000" Legacy¿ TurboSonics¿ Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 || Phacofragmentation system.
Device Recall CLEARTRAC COMPLETE, Threaded Cannula with Obturator
모델명 / 제조번호(시리얼번호)
122590, 123263, 123190, 122504, 122493, 122594, 123043, 122631, 122609, 122465, 122440, 122588, 122518, 122279, 122278, 122434, 122665.
의료기기 분류등급
Orthopedic Devices
의료기기 등급
1
이식된 장치?
No
유통
Nationwide Distribution.
제품 설명
- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 || - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631 || - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator, (Orange) 6.5mm x 72mm Ref. 72200427 Lot 122465 || - Crystal Cannula w/Obturator (Orange) 5.75mm I.D. X 7cm Ref. AR-6460 Lot 122594, 122518 || - Crystal Cannula, Partially Threaded, Distal End, w/Obturator, (Orange) 5.75mm I.D. x 7cm Ref. AR-6564 Lot 122493 || - Dry-Doc Cannula System w/ Obturator (Translucent Green) 5.0mm x 85mm Ref. C7350 Lot 123263 || - Dry-Doc Cannula w/ Obturator (Translucent Blue) 7.0mm x 85mm Ref. C7360 Lot 123263, 122594 || - Instrument Cannula w/Obturator w/"No Squirt Cap", (Purple) 7.0mm I.D. X 7cm Ref. AR-6550 Lot 122590 || - Partially Threaded Cannula and Obturator, w/o "No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6567* Lot 123043, 122278 || - PassPort Button Cannula" (Blue) 8mm ID x 4cm Ref. AR-6592-08-40 Lot 122594 || - Smooth Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214106 Lot 122465 || - Threaded Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214108 Lot 122665 || - Threaded Clear Cannula w/Obturator (Yellow) 8.5mm x 75mm Ref. 214120 Lot 122440, 122588 || - Threaded Clear Cannula w/Obturator, (Purple) 7.0mm x 75mm Ref. 214116 Lot 122465 || - Tibial Tunnel Cannula, Accomodates 9-12 mm Tunnel Diameters, (Blue) Ref. AR-1802D Lot 122594, 122279 || - Twist-In Cannula w/Obturator w/"No Squirt Cap", (Gold) 8.25mm I.D. X 7cm Ref. AR-6530 Lot 122590, 123190, 122665 || - Twist-In Cannula w/Obturator, w/ "No-Squirt" Cap, (Green) 6.0mm I.D. x 7cm Ref. AR-6535 Lot 122590, 122665 || - Twist-In Cannula w/Obturator, w/"No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6570 Lot 123190 || - Twist-In Cannula w/Obturator, w/o "No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6570* Lot 123043 || - Twist-In Cannula w/Obturator, w/o No Squirt Cap, (Gold) 8.25mm I.D. x 7cm Ref. AR-6530* Lot 122504, 122493, 123043 || - Universal Cannula w/Obturator, 76mm long (Green) 7.0mm Ref. 012421 Lot 123043 || - Universal Cannula, w/Obturator and Trocar (Blue) 5.0mm I.D. x 76mm Ref. 012405 Lot 123043, 122434 || Arthoscope
Device Recall ACCUPASS; ENDOSCRUB; Spectrum
모델명 / 제조번호(시리얼번호)
123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.
의료기기 분류등급
Orthopedic Devices
의료기기 등급
1
이식된 장치?
No
유통
Nationwide Distribution.
제품 설명
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 || - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 || - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 || - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 || Orthopedic manual surgical instrument.
하나 더 17 건 더
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