Events

Recall of Device Recall Synthes LCP DiaphysealMetaphyseal Volar Distal Radius Plate

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
    74082
  • Event Risk Class
    Class 2
  • Event Number
    Z-1949-2016
  • Event Initiated Date
    2016-05-02
  • Event Date Posted
    2016-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146232
  • 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
    Product incorrectly packaged. the labels on the outside of the box and on the lcp dia-meta volar distal radius plate inside the box are correct; however, the preprinted box which contains the lcp-dia-meta volar distal radius plate is incorrect. the box is preprinted for a 4.5 mm lcp condylar plate - distal femur.
  • Action
    DePuy Synthes sent out an Urgent Notice to customers informing them of a package mixup and the impact it could have on users. Customers were asked to evaluate their inventory and immediately remove the affected lot (9890811) from stock. Customers were asked to call DePuy Synthes at 1800-479-6329 to obtain a Return Authorization Number for return of the affected product, fill out the verification section of the letter and mail with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Any questions, they were said to call 610-719-5450 or to contact their DePuy Synthes Sales Consultant.

Device

Device Recall Synthes LCP DiaphysealMetaphyseal Volar Distal Radius Plate
  • Model / Serial
    Lot Number 9890811, Catalog ID 02.110.115S
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to one customer: Colorado
  • Product Description
    LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
  • 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