Events

Recall of Device Recall STRYKER 4.0 mm ANGLED AGGRESSIVE 12 DEGREE BLADE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Division of Stryker 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
    59057
  • Event Risk Class
    Class 2
  • Event Number
    Z-2794-2011
  • Event Initiated Date
    2011-06-13
  • Event Date Posted
    2011-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100967
  • 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
    Blade, saw, general, &, plastic surgery, surgical - Product Code GFA
  • Reason
    Recalled device was packaged with the incorrect angled blade. the labeling indicates a 12 degree angle but the product has a 40 degree angle.
  • Action
    Stryker Instruments Division of Stryker CorporationOn 6/13/11 sent an 'URGENT MEDICAL DEVICE RECALL NOTIIFICATION" letter to all affected customers that included the device name, lot number, dates of distribution, reason for the recall, risks associated with use of the device, a photo of the device, instructions to quarantine and return the devices, and a form to fax back to the firm to confirm receipt and adherence to the recall letter.

Device

Device Recall STRYKER 4.0 mm ANGLED AGGRESSIVE 12 DEGREE BLADE
  • Model / Serial
    Lot number 10265CG2, Part number 5290-744-100
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, LA,, MI, NJ, OH, OR, AR, IN, and Internationallly to Australia, Duisburg, Newbury and Hong Kong.
  • Product Description
    Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLY || For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation

Manufacturer

Stryker Instruments Division of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA