Events

Recall of T5766 Offset Reamer 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
    76236
  • Event Risk Class
    Class 2
  • Event Number
    Z-1190-2017
  • Event Initiated Date
    2016-10-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152568
  • 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
    On june 14, 2016, greatbatch discovered a significant increase in the number of field complaints for the t5766 offset reamer handle in which the u-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. the 2016 failure rate for this failure exceeds the occurrence rate as defined in the dfmea.
  • Action
    Consignee was sent via e-mail on 10/16/2016 a Greatbatch "Urgent Medical Device Recall" letter dated 10/19/2016 The letter described the purpose of the letter, Reason for Notification, Risk to Health, Recommendation, Instruction to Zimmer. Advised consignee to examine their inventory, quarantine the product and provide a list of the affected countries where the product was distributed. Also requested consignee to complete the Customer Notification Response form and return to Greatbatch at FieldActionCenter@Greatbatch.com. For questions contact your local Greatbatch Medical representative, Monday through Friday via telephone at 1-763-951-8235 8:00 AM (CT) to 5:00 PM (CT), or e-mail us at FieldActionCenter@Greatbatch.com .

Device

T5766 Offset Reamer Handle
  • Model / Serial
    2481193, 2468380, 2599785, 2463309, 2468379, 2468398, 2468397, 2599516, 2671555, 2599517, 2670543, 2671558, 2734809, 2814828, 2814829, 2824496, 2858434, 2865404, 3030658, 2944397, 2977852, 2967214, 3000586, 3000590, 3030658, 3044689, 3071903, 3135658, 3088675, 3107504, 3188688, 3385844, 3188690, 3387046, 3397768.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of IN and the countries of Canada, Austria, Germany, Japan.
  • Product Description
    Offset Reamer Handle, T5766 || Product Usage: || The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are intended for use with a surgical driver (active device). The reamer handle is connected at the distal end to a reamer. The T5766 reamer handle is an offset design with a drive shaft mechanism that spins on roller bearings and is encapsulated in an inner clam shell housing that is constrained within a Radel¿ tube and outer housing.
  • 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