Events

Recall of Synthes Flexible Shaft

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
    75580
  • Event Risk Class
    Class 2
  • Event Number
    Z-0656-2017
  • Event Initiated Date
    2016-10-31
  • Event Date Posted
    2016-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150844
  • 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 - Product Code HTO
  • Reason
    Non-conforming material used.
  • Action
    The firm, DePuy Synthes, mailed an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 11/2016 to customers who were affected by the recall. The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory to identify and quarantine all affected products; if you have product to return call DePuy Synthes at 1-800-479-6329 to obtain an RA; complete and return the Verification Section with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 within 30 business days; send a copy of the completed Verification section via fax to 888-257-7905 or scan/email: Synthes3503@stericycle.com, even if you have no product to return; forward notice to anyone in your facility that needs to be informed; if any of the affected product has been forwarded to another facility, contact that facility to arrange return and keep a copy of the notice. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Device

Synthes Flexible Shaft
  • Model / Serial
    Part Number 352.040 - Lot # 9947895, L084498  Part Number 352.044 - Lot # 9916503 9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632 L082974
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Synthes Flexible Shaft, Orthopedic manual surgical instrument || The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
  • 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