Events

Recall of Device Recall MiniMagnum Knotless Fixation Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ArthroCare Corporation.

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
    59978
  • Event Risk Class
    Class 2
  • Event Number
    Z-0049-2012
  • Event Initiated Date
    2011-05-11
  • Event Date Posted
    2011-10-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104144
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    Arthrocare initiated the recall of one lot of the minimagnum knotless implant fixation device where the incorrect diver block was packed with the implant.
  • Action
    The firm, ArthroCare Corporation, sent a letter dated May 10, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were asked to immediately return the product; check their inventory, refer to the copy of the Mini Magnum outer label to help identify the product, and if the affected product lot is in their inventory, notify ArthoCare Product Support at (800) 797-6520, press 2 and return the product immediately. The letter also stated, "In addition, if you do not have any product from this lot remaining in your inventory, we request that you contact ArthroCare at the number above, or by e-mail at ra@arthrocare.com, to inform us of the lack of remaining product. This will ensure that you will not be contacted again and that we have accounted for product shipments from this lot." If you have any questions, please call the Chief Regulatory Officer and Senior Vice President, Quality Systems and Assurance at (408) 735-6229.

Device

Device Recall MiniMagnum Knotless Fixation Device
  • Model / Serial
    Lot Number: 1015833
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: USA including states of: CA, FL, NY, OH and OK.
  • Product Description
    ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007; || Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CA || The MiniMagnum Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-Iabral reconstruction, biceps tenodesis and deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
  • Manufacturer
    ArthroCare Corporation

Manufacturer

ArthroCare Corporation
  • Manufacturer Address
    ArthroCare Corporation, 680 Vaqueros Ave, Sunnyvale CA 94085-3523
  • Source
    USFDA