Events

Recall of Torque Limiting Handle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Greatbatch Medical.

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
    73948
  • Event Risk Class
    Class 2
  • Event Number
    Z-1882-2016
  • Event Initiated Date
    2016-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145589
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Reason
    Greatbatch medical has initiated a global field recall for torque limiting devices. greatbatch identified through laboratory testing that the required sterility assurance level (sal) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the instruction for use (ifu) provided with the device.
  • Action
    Consignees were sent on 4/26/2016 a Greatbatch "Urgent Medical Device Recall" letter dated April 26, 2016. The letter described the product involved in the recall, the reason, and the risk to health. The letter advised consignees to identity and quarantine the product and to complete and return the Filed Recall Response Form. For questions contact your local Greatbatch Medical representative, at 1-763-951-8235, or e-mail FieldActionCenter@Greatbatch.com.

Device

Torque Limiting Handle
  • Model / Serial
    6307760001
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.
  • Product Description
    Torque Limiting Handle: || PRECIMED, T-Handle Torque, Non Sterile. || Handle: || Customer Number/Model: || MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, || TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, || TLT911-35-S01 TLT911-35-S01.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Manufacturer Address
    Greatbatch Medical, 2300 Berkshire Ln N, Plymouth MN 55441-4575
  • Manufacturer Parent Company (2017)
    Integer Holdings Corporation
  • Source
    USFDA