Events

Recall of Device Recall Wedge HS Suture Anchor II, 6.5 mm with Needles

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

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
    46916
  • Event Risk Class
    Class 2
  • Event Number
    Z-1538-2008
  • Event Initiated Date
    2008-02-07
  • Event Date Posted
    2008-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68501
  • 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
    Soft Tissue Fixation Fastener - Product Code MBI
  • Reason
    Product package may crack and cause loss of sterility.
  • Action
    Stryker Endoscopy initiated the recall on 02/07/2008 by notifying its consignees via telephone, as well as sending out Urgent: Device Removal notices. Recipients of affected lots are to inspect their inventory for part/lot numbers and quarantine any affected product. Affected products are to be returned to Stryker Endoscopy and Customer Service should be contacted for replacement alternatives. Also, the "Acknowledgment of recipt" card needs to be signed and returned to Stryker Endoscopy.

Device

Device Recall Wedge HS Suture Anchor II, 6.5 mm with Needles
  • Model / Serial
    Lot Numbers 07299AE2
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.
  • Product Description
    Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 || Intended for use in securing soft tissue to bone in certain procedures in specific areas.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138
  • Source
    USFDA