Events

Recall of Device Recall Offset Cup Impactor

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
    67392
  • Event Risk Class
    Class 1
  • Event Number
    Z-1119-2014
  • Event Initiated Date
    2014-01-31
  • Event Date Posted
    2014-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125387
  • 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
    Impactor - Product Code HWA
  • Reason
    Greatbatch medical has initiated a global field corrective action for the standard offset cup impactor since the product was first released in 2004. greatbatch has identified through internal sterility assurance level validation testing that a sterility assurance level of 10-6 is not achieved on the standard offset cup impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current instructions for use (ifu) provided with the device. the standard offset cup impactor is provided non-sterile and must be sterilized prior to use in a surgery. greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
  • Action
    Greatbatch sent an Urgent Medical Device Field Corrective Action letter dated January 31, 2014, to all affected consignees. The letter was addressed to "Dear Valued Customer". The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. The instructions to customers included to review the enclosed Field Corrective Action Response Form, to examine their inventory and identify all Standard Offset Cup Impactors that are in their possession and immediately inform those responsible for sterilization to utilize the updated instructions. Also, advised consignees to immediately notify all customers of the Field Corrective Action and to complete and return the Field Corrective Action Response Form. For questions consignees were instructed to contact their local Greatbatch Medical representative at 1-763-951-8235 or e-mail them at FieldActionCenter@Greatbatch.com. For questions regarding this recall call 763-951-8235. UPDATED 3-28-2014: An updated Urgent Medical Device Correction letter was sent out to consignees 3/28/2014 to tell them of an additional validated sterilization parameter in addition to additional devices that are affected by the recall. A notice was asked to be posted where sterilization of the Standard Offset Cup Impactors occurs so personnel responsible for the sterilization of the devices would see the 2 validated cycles. A response form was asked to be returned to Greatbatch.

Device

Device Recall Offset Cup Impactor
  • Model / Serial
    all lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, IN, KS, MA, NJ, TN,TX,UT and Internationally to Australia, Austria, Belgium, China, France, Germany, Greece, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
  • Product Description
    Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384, T15311, T15752, T15822, T15949, T16117, T16427, T16604, T16611, T16661, T16829, T16934, T17062, T17203, T17238, T17321, T6318, T7821, T8042, T8043, T8044, T8087, T8088, T8093, T8095, T8177, T8184, T8277, T8310, T8333, T8468, T8487, T9109, T9196, T9205, T9316, T9348, T9360, T9556, T9557, T9747, T9894, T9954, T9955, T9999. || The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA). || EXPANDED 3-28-2014: The following Part Numbers are also affected: P10270, P6427, P6464, P6501, P7611, P7640, P7794, P7927, P8233, P8590, T10006, T10261, T10606, T10835, T11095, T11506, T11622, T12081, T12083, T12124, T12125, T13435, T13527, T14174, T15262, T15515, T16418, T16551, T16552, T16553, T17272, T5709, T6744, T7751, T9195.
  • Manufacturer
    Greatbatch Medical

Manufacturer

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