Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Abrader; AcromioBlaster; CoolCut; Dyonics; Elite; Formula; Gator; Great White; Incisor; RazorCut; Sy

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Abrader; AcromioBlaster; CoolCut; Dyonics; Elite; Formula; Gator; Great White; Incisor; RazorCut; Sy see related information
Date Initiated by Firm May 03, 2013
Date Posted July 01, 2013
Recall Status1 Terminated 3 on July 11, 2013
Recall Number Z-1633-2013
Recall Event ID 65205
510(K)Number K012667  
Product Classification Arthroscope - Product Code HRX
Product - 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 B
Code Information 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.
Recalling Firm/
Manufacturer		 Surgical Instrument Service And Savings, Inc.
2747 Sw 6th St
Redmond OR 97756-7109
For Additional Information Contact Rich Wynkoop
866-866-7477
Manufacturer 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.
FDA Determined
Cause 2		 Packaging process control
Action MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.
Quantity in Commerce 907
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
-
-