Events

Recall of Device Recall Cannulated Drill bit 2.0mm and 2.6 mm

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

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
    76156
  • Event Risk Class
    Class 2
  • Event Number
    Z-1113-2017
  • Event Initiated Date
    2016-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152401
  • 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
    The product is being recalled due to incidence and reports of the product breaking during surgery.
  • Action
    Flower Orthopedics mailed a letter to customers on December 22, 2016 making them aware of the issue. Customers were asked to return the affected product and to report if any adverse effects resulted from its use.

Device

Device Recall Cannulated Drill bit 2.0mm and 2.6 mm
  • Model / Serial
    Device Listing: D267957
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed throughout the United States
  • Product Description
    Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
  • Manufacturer
    Flower Orthopedics Corporation

Manufacturer

Flower Orthopedics Corporation
  • Manufacturer Address
    Flower Orthopedics Corporation, 100 Witmer Rd Ste 280, Horsham PA 19044-2647
  • Manufacturer Parent Company (2017)
    Flower Orthopedics Corp.
  • Source
    USFDA