Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Surgical Instrument Service And Savings, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65205
  • Event Risk Class
    Class 2
  • Event Number
    Z-1633-2013
  • Event Initiated Date
    2013-05-03
  • Event Date Posted
    2013-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118477
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Arthroscope - Product Code HRX
  • Reason
    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
  • 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.

Device

Device Recall Abrader; AcromioBlaster; CoolCut; Dyonics; Elite; Formula; Gator; Great White; Inc...
  • Model / Serial
    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 Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • 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 B
  • Manufacturer
    Surgical Instrument Service And Savings, Inc.

Manufacturer

Surgical Instrument Service And Savings, Inc.
  • Manufacturer Address
    Surgical Instrument Service And Savings, Inc., 2747 Sw 6th St, Redmond OR 97756-7109
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA