Events

Recall of Device Recall The Spetzler Claw"

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. 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
    73610
  • Event Risk Class
    Class 2
  • Event Number
    Z-1378-2016
  • Event Initiated Date
    2016-03-22
  • Event Date Posted
    2016-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144573
  • 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
    Instrument, ultrasonic surgical - Product Code LFL
  • Reason
    The spetzler claw tip was packaged with the incorrect tip sleeve assembly. the tip sleeve assembly included in the packaging is the incorrect size. risk to health: if the tip sleeve assembly does not fit the spetzler claw" tip, a surgical delay may occur while an alternate tip sleeve assembly is retrieved.
  • Action
    On 3/22/2016, URGENT MEDICAL DEVICE RECALL NOTIFICATION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Kara Spath 269-389-4518 kara.spath@stryker.com

Device

Device Recall The Spetzler Claw"
  • Model / Serial
    5450-800-311  Lot Number 0545410 5450-800-313  Lot Number 0555170
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AZ, CA, CO, CT, IL, IN, MD, MI, MN, NY, PA, SC, TN, WA, WI, and VA, and in the NETHERLANDS.
  • Product Description
    Spetzler Claw Tip, Universal - 5450-800-311 || Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 || The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments intended to be used with the Sonopet Ultrasonic Handpiece.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA