Events

Recall of Pinnacle Cure Sleeve

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

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
    63583
  • Event Risk Class
    Class 2
  • Event Number
    Z-0444-2013
  • Event Initiated Date
    2011-09-20
  • Event Date Posted
    2012-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114255
  • 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
    Cover, barrier, protective - Product Code MMP
  • Reason
    The firm initiated the recall due to a labeling error. the boxes labeled as pinnacle cure sleeve 4511, which fits 11mm light guides, actually contain pinnacle cure sleeves that fit 7mm or 8mm light guides (part number 4500).
  • Action
    The firm, Sybron Dental Specialties, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 20, 2011 to its consignees/customers. The consignees/customers were instructed to determine if they have any of the affected product in their inventory; if they have the affected product to contact Metrex Research Customer Care at 1-800-841-1428 to receive an RMA number; return any affected product in their inventory; and complete and return the Recall Response Form via mail to: Metrex Research, 29210 Wick Road, Romulus, Michigan 48174, Attn: QA Lab or fax to: 734-947-6725. If you have any questions regarding this recall, you can contact our Customer Care Center at 1-800-841-1428.

Device

Pinnacle Cure Sleeve
  • Model / Serial
    Part Number Lot Number  4511 201008270110
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
  • Product Description
    Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier || The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
  • Manufacturer
    Metrex Research, LLC.

Manufacturer

Metrex Research, LLC.
  • Manufacturer Address
    Metrex Research, LLC., 28210 Wick Rd, Romulus MI 48174-2639
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA