Events

Recall of Device Recall Synthes

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
    72774
  • Event Risk Class
    Class 2
  • Event Number
    Z-0585-2016
  • Event Initiated Date
    2015-12-01
  • Event Date Posted
    2016-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142186
  • 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
    Reamer. Manual surgical orthopedic instrument - Product Code HTO
  • Reason
    The 13.5mm medullary reamer head, lot #f-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
  • Action
    On Dec 1, 2015, Synthes issued a recall notification letter and requested that all consignees review inventory and contact Synthes for a return authorization number. The verification form is to be completed and sent to Stericycle.

Device

Device Recall Synthes
  • Model / Serial
    Part number: 352.135;  Lot number: F-17180
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US nationwide distibution.
  • Product Description
    SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
  • 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