Events

Recall of Device Recall STRYKERArthroscopic Blade

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

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
    58937
  • Event Risk Class
    Class 2
  • Event Number
    Z-0959-2012
  • Event Initiated Date
    2009-01-26
  • Event Date Posted
    2012-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105460
  • 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
    On 01/26/2009, ascent healthcare solutions, lakeland, fl initiated a recall of various models of dyonics, stryker, and linvatech reprocessed arthroscopic shaver blades. the sterility of the devices may be compromised due to a potential breach in the seal of the tyvek cover to the plastic tray.
  • Action
    Ascent Healthcare Solutions sent an "URGENT MEDICAL DEVICE VOLUNTARY RECALL" letter dated January 26, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to examine their inventory, remove and quarantine all affected devices. A Recall Effectiveness Check Form was attached for customers to complete and return via fax to 1-866-325-4760. Contact the firm at (888) 888-3433 ext. 5519 for questions regarding this recall.

Device

Device Recall STRYKERArthroscopic Blade
  • Model / Serial
    Lot numbers: 195749, 199469 and 192516.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, and WY, and the country of Canada.
  • Product Description
    ***CAT 375-532-000***STRYKER***Arthroscopic Blade***3.5mm RESECTOR***Hub Style - Formula***Yellow/Black***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 195749***Expiration Date: 11/2011. || ***CAT 375-542-000***STRYKER***Arthroscopic Blade***4.0mm RESECTOR***Hub Style - Formula***Red/Black***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 199469***Expiration Date: 12/2011. || ***CAT 375-562-000***STRYKER***Arthroscopic Blade***5.5mm RESECTOR***Hub Style - Formula***Tan/Black***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 192516***Expiration Date: 10/2011. || Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
  • Manufacturer
    Ascent Healthcare Solutions

Manufacturer

Ascent Healthcare Solutions
  • Manufacturer Address
    Ascent Healthcare Solutions, 10232 S 51st St, Phoenix AZ 85044-5205
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA