Events

Recall of Device Recall CLAW(R) II 2 HOLE PLATE ORTHOLOC(TM) 3DSi, LENGTH 30mm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wright Medical Technology, Inc..

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
    69058
  • Event Risk Class
    Class 2
  • Event Number
    Z-2604-2014
  • Event Initiated Date
    2014-07-30
  • Event Date Posted
    2014-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129464
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    Plates manufactured from an incorrect raw material.
  • Action
    Wright Medical sent an Urgent Medical Device Recall letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product and immediately quarantine all affected product and return to Wright Medical as soon as possible. For return instructions customers were instructed to contact Customer Service at 800-238-7117. Customers were also asked to complete the attached response form, confirming receipt of the notice and the status of the product(s) on hand and return by fax to 901-867-7401. Customers with questions were instructed to call 901-290-5662. For questions regarding this recall call 800-238-7117.

Device

Device Recall CLAW(R) II 2 HOLE PLATE ORTHOLOC(TM) 3DSi, LENGTH 30mm
  • Model / Serial
    Lot Numbers: 1487670, 1487671, 1487672, 1512149, 1519496, 1523745, 1534796, 1537159, 1539400, 1540714
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.
  • Product Description
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE || Orthopedic
  • Manufacturer
    Wright Medical Technology, Inc.

Manufacturer

Wright Medical Technology, Inc.
  • Manufacturer Address
    Wright Medical Technology, Inc., 1023 Cherry Rd, Memphis TN 38117-5423
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA