• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description 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 Blade, Large Hub, Sterling, Shaver (Orange) 3.5mm Ref. C9264 Lot 122592 - Gator Blade, Large Hub, Sterling, Shaver (Orange) 4.2mm Ref. 92563A Lot 123263 - Gator Blade, Micro Hub, Sterling 7.6cm, (Orange) 3.5mm Ref. C9962 Lot 123353 - Gator Blade, Micro Hub, Sterling, Shaver 7.6cm, (Orange) 2.9mm Ref. C9961 Lot 123263 - Gator Blade, Large Hub, Sterling, Working Length: 8.2cm, (Orange) 2.9mm Ref. C9961A Lot 122511 - Great White Blade, Sterling, Large Hub (White) 4.2mm Ref. 9299A Lot 123263, 122592, 122482, 123353 - Great White Blade, Sterling, Large Hub (White) 5.5mm Ref. 9599A Lot 123353, 122511 - Great White Blade, Large Hub, Merlin, Pre-Bent 15 Degree Max., (White/Black) 4.2mm Ref. C9299P Lot 123353 - Great White Blade, Large Hub, Sterling, Shaver, (White) 3.5mm Ref. 9399A Lot 123263, 122592, 123353 - HeliCut, Burr (Slate) 4.5mm Ref. 7205727 Lot 122609 - Incisor Blade (Lime Green) 4.5mm Ref. 7205313 Lot 122454 - Incisor Blade, (Medium Grey) 3.5mm Ref. 7205312 Lot 123270 - Incisor Plus Blade (Teal) 5.5mm Ref. 7205459 Lot 122609, 122465, 123270 - Incisor Plus Blade, (Violet) 4.5mm Ref. 7205345 Lot 122338, 122609, 122465, 123270, 122434, 122665 - INCISOR Plus ELITE (Slate) 4.5mm Ref. 7210976 Lot 122590 - INCISOR Plus ELITE (White) 3.5mm Ref. 72200095 Lot 122465 - Inferior Turbinate Blade M4 Rotatable, Straight, w/o Tubing, 11 cm Length, (White) 2.9mm Ref. 18-8290HR(a) Lot 122465, 122440 - Inferior Turbinate Blade, M4 Rotatable, w/Tubing, (White) 2.0mm Ref. 18-82040HR Lot 122289, 122440 - Inferior Turbinate Blade, w/o Tubing (White) 2.9mm Ref. 18-82940(a) Lot 122590, 122482 - Inferior Turbinate Blade, w/o Tubing 2.0mm Ref. 18-82040(a) Lot 122609 - Micro-Joint Gator Blade, Micro Hub, Sterling, 7.6cm, (Orange) 2.0mm Ref. C9960 Lot 123353 - Oval Bur, High Speed, Large Hub, Sterling (Purple) 4.0mm Ref. H9101 Lot 123263 - Oval Bur, High Speed, Large Hub, Sterling (Purple) 5.0mm Ref. H9103RH Lot 123353 - Oval Bur, High Speed, Large Hub, Sterling, 20 Degree Reduced Hood, (Purple) 4.0mm Ref. H9101RH Lot 122592, 122511 - Oval Bur, Large Hub, Sterling, High Speed (Purple) 6.0mm Ref. H9102 Lot 123263, 122592, 122511 - RazorCut (Purple) 3.5mm Ref. 7205317 Lot 122465 - Rhinotec, Spherical Bur, Micro Hub, Sterling 7.6cm, (Blue) 2.9mm Ref. C9911 Lot 123353 - Series 3000 BoneCutter Blade, Full Radius, (Black/Yellow) 4.5mm Ref. 7206011 Lot 122590, 122609, 122465 - Spherical Bur, Large Hub, Sterling, High Speed, (Blue) 3.5mm Ref. H9110 Lot 123263, 122511 - Spherical Bur, Large Hub, Sterling, High Speed, (Blue) 4.5mm Ref. H9111 Lot 123263, 122511 - Synovator (Forest Green) 4.5mm Ref. 7205310 Lot 122609 - Tiger Blade, Large Hub, Sterling, Shaver (Black) 4.2mm Ref. C9242 Lot 122511 - Tricut Blade w/o Tubing, 11cm, (White) 4.0mm Ref. 18-8400(a) Lot 122590, 122482, 123270 - Tricut Blade, M4 Rotatable, w/o Tubing, (White) 4.0mm Ref. 18-84004HR* Lot 122465 - Tricut Blade, M4 Rotatable, w/Tubing, (White) 4.0mm Ref. 18-84004HR Lot 122289, 122440, 122279 - TurboTrimmer Blade (Powder Blue) 4.5mm Ref. 7205315 Lot 122347 - TurboWhisker Blade (Navy Blue) 4.5mm Ref. 7205316 Lot 122590, 122609 - UltraCut Blade, Large Hub, Sterling Shaver, Dual Purpose Blade, (Slate/Grey) 4.2mm Ref. C94505A Lot 123353, 122511 - UltraCut Full Radius Resector, Sterling, Shaver, Large Hub, (Blue/Grey) 5.5 mm Ref. C9415 Lot 122592, 122511 - Vortex Router, Large Hub, Sterling, Hooded, High Speed, (Green) 4.5mm Ref. H9131 Lot 123263, 122592 - Vortex Router, Large Hub, Sterling, Hooded, High Speed, (Dk. Green) 6.0mm Ref. H9132 Lot 123263, 122592
Recall Number Z-1633-2013
Classification Class II
Code Info 122590, 122338, 123263, 122347, 123190, 122493, 122594, 122592, 122482, 122490, 122631, 122289, 123353, 122609, 122465, 122440, 123270, 122588, 122518, 122309, 122279, 122278, 122434, 122665, 122511.
Product Distributed Qty 907
Reason For Recall The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Event Detail

Event Id 65205
Product Type Devices
Status Ongoing
Recalling Firm Surgical Instrument Service And Savings, Inc.
City Redmond
State OR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.
-
-