Recall of Device Recall Hex Driver

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
    79224
  • Event Risk Class
    Class 2
  • Event Number
    Z-1373-2018
  • Event Initiated Date
    2018-01-11
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Following the completion of sterilization cycle(s) of the impacted hex driver, the epoxy color band on the impacted hex driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.
  • Action
    Recall notification letters were sent to affected consignees on January 16, 2018. The consignee letter requests that the consignee return an initial Acknowledgement & Receipt Form to TriMed by January 23, 2018.

Device

  • Model / Serial
    Affected lot numbers: 922361, 922362, 91956, 91957, 92237, 92238, 91858, 92235, 92656, 91856, 91857
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, China, Latin America
  • Product Description
    Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
  • Manufacturer

Manufacturer

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