Events

Recall of Orthopedic Devices

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products LLC.

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
    72330
  • Event Risk Class
    Class 2
  • Event Number
    Z-0124-2016
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140637
  • 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 2.7mm/3.5mm va-lcp humerus plates were found to be labeled incorrectly. part number 02.117.410s was incorrectly etched with part number 02.117.610s.
  • Action
    The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 9/28/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s). " Complete the Verification Section (page 3 of this letter), (even if you do not have the product) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. " Return the Verification Section (page 3 of this letter) with the product to: " Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. " Send a copy of the completed Verification Section by: " Fax: 844-294-7175 or " Scan/email: Synthes4672@stericycle.com " Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification. If you have any questions, please call 610-719-5450.

Device

Orthopedic Devices
  • Model / Serial
    Product Description Part Numbers Lot Numbers 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile 02.117.410S 8009075 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile 02.117.610S 8007085
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of:OH, IL, PA, WV, FL, AZ, CA, AL, ND, KY, MN, NJ, MI, GA, IN, TN, VA, NC, and LA.
  • Product Description
    Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile || The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, " Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. " Olecranon and proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA