Surgical Instrument Service And Savings, Inc.

FDA Regulatory Profile

Summary

Total Recalls
22
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1626-2013Class IIGII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 LotMay 3, 2013
Z-1630-2013Class II- Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated DrillMay 3, 2013
Z-1632-2013Class IIBarron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 OpthaMay 3, 2013
Z-1627-2013Class II-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFMay 3, 2013
Z-1623-2013Class II-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 May 3, 2013
Z-1641-2013Class II- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631May 3, 2013
Z-1640-2013Class II- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel May 3, 2013
Z-1643-2013Class II- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA LoMay 3, 2013
Z-1629-2013Class II- Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 ManuMay 3, 2013
Z-1625-2013Class II-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122May 3, 2013
Z-1634-2013Class IILarge Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument fMay 3, 2013
Z-1644-2013Class IIHarmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cmMay 3, 2013
Z-1638-2013Class II- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT1May 3, 2013
Z-1639-2013Class II- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva LumMay 3, 2013
Z-1624-2013Class II- ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 1225May 3, 2013
Z-1628-2013Class II-90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 720May 3, 2013
Z-1633-2013Class II- Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mmMay 3, 2013
Z-1631-2013Class II- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm LMay 3, 2013
Z-1642-2013Class II- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 May 3, 2013
Z-1635-2013Class II- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank May 3, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerDecember 19, 2025
K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CathetNovember 26, 2025
K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheteJuly 11, 2025
K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, June 5, 2025
K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (082March 10, 2025
K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterNovember 29, 2024
K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme ElectrophySeptember 14, 2024
K234064Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (1013September 10, 2024
K240972Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)June 7, 2024
K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)April 29, 2024
K221067Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterMay 31, 2023
K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsJuly 3, 2019
K182828Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserApril 15, 2019
K180580Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation DevicesJuly 27, 2018
K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorJuly 12, 2018
K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsNovember 9, 2017
K172608Medline ReNewal Reprocessed Stryker SERF AS Energy ProbesOctober 18, 2017
K161358Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsAugust 3, 2017
K171324Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew DyonicsJune 23, 2017
K161272Supreme and Response Electrophysiology CathetersMay 18, 2017