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Anspach Carbide Cutting Burrs & Drums recallZ-0728-2014 · The Anspach Effort, Inc. · initiated Dec 17, 2013

Class II Terminated All recalls posted in January 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from The Anspach Effort, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Some carbide cutting burr fractured during use.

FDA root cause category: Process design

What the company is doing

The firm, Anspach, sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated December 19, 2013 to their costumers. The letter described the product, problem and actions to be taken. The customers were instructed to complete the attached reply form confirming your receipt of this letter and return the completed form by Fax to: 1-800-327-6661 or Email: [email protected]. Reference RMA 200059216 when returning any devices. If you distribute(d any of the products to other services or facilities, please forward this information as appropriate . Should you have any queries please do not hesitate to contact Anspach Customer Support at 800-327-6887 or e-mail at [email protected].

Recall details

Recall number
Z-0728-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 17, 2013
Posted by the FDA
Jan 13, 2014
Recalling firm
The Anspach Effort, Inc.
Quantity
28,562 total of all products in this recall
Product code
HBE
FDA submissions
K080802
Distribution
Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.

Product description

Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

Code information (models, lots, serial numbers)

All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)

Other devices under the same FDA submission

11 devices cleared under K080802 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 67146).

Sources and updates

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