Events

Recall of Device Recall OCM Cutting Burrs (Cutters)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Anspach Effort, Inc..

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
    73738
  • Event Risk Class
    Class 2
  • Event Number
    Z-1668-2016
  • Event Initiated Date
    2016-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144999
  • 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
    Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
  • Reason
    Certain lots of the otologic curved micro (ocm) diamond ball burrs may be missing the diamond coating and the ball may be the incorrect size.
  • Action
    Consignees were sent an Urgent Notice of this Medical Device Recall on 3/28/2016 for their product Otologic Curved Micro (OCM) Diamond Ball Burr, with the following actions required: We have record that your facility has the product(s) subject to this recall (removal). DePuy Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO HAVE any of the identified devices, please take the following steps: Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Please contact Product Support at (800) 327-6887, option 1, to arrange for return of any unused product. A credit will be issued for returned product. Send a copy of the completed Verification Section (page 3) to Product Support by fax to (561) 627-2682. Send a copy of the completed Verification Section (page 3) to the Complaint Handling Unit by scan/email to RA-DPYUS-chu.pb@ITS.JNJ.com. If you DO NOT HAVE the identified product, please take the following steps: Complete the Verification Section by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device recall (removal) information. ¿ Return the documents to The Anspach Effort by: ¿ Fax: (561) 627-2682 ¿ Scan/email: RA-DPYUS-chu.pb@ITS.JNJ.com ¿ Giving them to your DePuy Synthes Sales Consultant ¿ Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual of the notification.

Device

Device Recall OCM Cutting Burrs (Cutters)
  • Model / Serial
    Model/Catalog #: OCM7-2SD, 2.0 MM Diamond Ball, Lot Numbers: J473111699.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in the states of KY and TX.
  • Product Description
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD || Product Usage: || The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • Manufacturer Address
    The Anspach Effort, Inc., 4500 Riverside Dr, Palm Beach Gardens FL 33410-4235
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA