Surgical Instrument Service And Savings, Inc.
Surgical Instrument Service And Savings, Inc. appears in FDA public data with 22 recalls, 23 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1630-2013, Class II) was initiated on May 3, 2013. Its most recent 510(k) clearance was granted on December 19, 2025.
Summary
- Total Recalls
- 22
- 510(k) Clearances
- 23
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1630-2013 | Class II | - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill | May 3, 2013 |
| Z-1632-2013 | Class II | Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Optha | May 3, 2013 |
| Z-1629-2013 | Class II | - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manu | May 3, 2013 |
| Z-1628-2013 | Class II | -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 720 | May 3, 2013 |
| Z-1633-2013 | Class II | - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm | May 3, 2013 |
| Z-1638-2013 | Class II | - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT1 | May 3, 2013 |
| Z-1634-2013 | Class II | Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument f | May 3, 2013 |
| Z-1639-2013 | Class II | - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Lum | May 3, 2013 |
| Z-1641-2013 | Class II | - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631 | May 3, 2013 |
| Z-1640-2013 | Class II | - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel | May 3, 2013 |
| Z-1627-2013 | Class II | -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureF | May 3, 2013 |
| Z-1623-2013 | Class II | -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 | May 3, 2013 |
| Z-1643-2013 | Class II | - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lo | May 3, 2013 |
| Z-1625-2013 | Class II | -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122 | May 3, 2013 |
| Z-1644-2013 | Class II | Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm | May 3, 2013 |
| Z-1636-2013 | Class II | - IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pin | May 3, 2013 |
| Z-1631-2013 | Class II | - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm L | May 3, 2013 |
| Z-1626-2013 | Class II | GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot | May 3, 2013 |
| Z-1637-2013 | Class II | TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. | May 3, 2013 |
| Z-1642-2013 | Class II | - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 | May 3, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | December 19, 2025 |
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Cathet | November 26, 2025 |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Cathete | July 11, 2025 |
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, | June 5, 2025 |
| K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (082 | March 10, 2025 |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | November 29, 2024 |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophy | September 14, 2024 |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (1013 | September 10, 2024 |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | June 7, 2024 |
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | April 29, 2024 |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter | May 31, 2023 |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | July 3, 2019 |
| K182828 | Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer | April 15, 2019 |
| K180580 | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices | July 27, 2018 |
| K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | July 12, 2018 |
| K171911 | Medline ReNewal Reprocessed Synthes External Fixation Systems | November 9, 2017 |
| K172608 | Medline ReNewal Reprocessed Stryker SERF AS Energy Probes | October 18, 2017 |
| K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | August 3, 2017 |
| K171324 | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics | June 23, 2017 |
| K161272 | Supreme and Response Electrophysiology Catheters | May 18, 2017 |