Events

Recall of Smith & Nephew PERILOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, 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
    72655
  • Event Risk Class
    Class 2
  • Event Number
    Z-0372-2016
  • Event Initiated Date
    2015-10-20
  • Event Date Posted
    2015-12-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141840
  • 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
    The devices were packaged and laser marked anatomically incorrect. the left plates were laser marked and packaged as right plates and the right plates were laser marked and packaged as left plates.
  • Action
    Distributors, notified by Fed- Ex on 10/20/2015, were asked to quarantine the product and return it.

Device

Smith & Nephew PERILOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE
  • Model / Serial
    Batch # 14KT47574
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    International only Germany, Japan, Russia
  • Product Description
    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA