Events

Recall of Device Recall TriMed SemiTubular Plate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Trimed 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
    75080
  • Event Risk Class
    Class 2
  • Event Number
    Z-2849-2016
  • Event Initiated Date
    2016-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149324
  • 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
    Trimed is recalling the semi-tubular plates with 10 holes (smtp-10) because a non-locking screw passed through a hole in a smtp-10 plate being implanted.
  • Action
    The firm, TriMed, sent a "Medical Device Recall Notification" Letter dated 8/29/16 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product subject to this recall; notify your customers at once of this product recall; discontinue use; return product, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form as soon as possible by Fax to: 1-661-254-8485 or email to: davidmedoff@trimedortho.com. Customers with questions are instructed to contact Director of Operations at (800) 633-7221, davidmedoff@trimedortho.com, M-F, 9am-5pm, Pacific Standard.

Device

Device Recall TriMed SemiTubular Plate
  • Model / Serial
    Lot no. 06206
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.
  • Product Description
    TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 || Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.
  • Manufacturer
    Trimed Inc

Manufacturer

Trimed Inc
  • Manufacturer Address
    Trimed Inc, 27533 Avenue Hopkins, Santa Clarita CA 91355-3910
  • Manufacturer Parent Company (2017)
    Trimed Incorporated
  • Source
    USFDA