Events

Recall of PHALINX (TM) HAMMERTOE HANDLE, SIZE: XSMALL, STYLE: ANGLED, REF 45304011

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
    71143
  • Event Risk Class
    Class 2
  • Event Number
    Z-1624-2015
  • Event Initiated Date
    2015-04-16
  • Event Date Posted
    2015-05-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136231
  • 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 term dorsal was laser etched on the incorrect side on some of the angled handles.
  • Action
    Wright sent an Urgent Medical Device Recall letter dated April 13, 2015, 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, send it back to Wright Medical as soon as possible. Contact Customers Service at 901-867-4575 for return instructions and replacement inventory. Customers were instructed to complete the attached response immediately, confirming their receipt of this notice and the status of any product(s) on had, and return a copy by email to complaints@wmt.com or fax to 901-867-7401. Customers with questions should call 901-451-6144.

Device

PHALINX (TM) HAMMERTOE HANDLE, SIZE: XSMALL, STYLE: ANGLED, REF 45304011
  • Model / Serial
    Lot 1344534
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
  • 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