Events

Recall of Device Recall Stryker

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
    30759
  • Event Risk Class
    Class 2
  • Event Number
    Z-0401-05
  • Event Initiated Date
    2004-12-27
  • Event Date Posted
    2005-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36544
  • 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
    The label on the outside of the shipping box has an incorrect description of the screw diameter.
  • Action
    Consignees have been alerted by phone calls on 12/16/2004. Formal advisory notice was sent out on 12/27/2004. All international consignees have also been alerted.

Device

Device Recall Stryker
  • Model / Serial
    Part Number: 234-010-078, Lot # 32101;  Part Number: 234-010-080, Lot # 32103
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    6 consignees (locations to be determined) received 15 units. the remaining 147 units were distributed to international divisions.
  • Product Description
    Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm || Part Numbers: 234-010-078; 234-010-080
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA