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Anspach MCA Cutting Burr, DFU Rx Only recallZ-0715-2014 · The Anspach Effort, Inc. · initiated Mar 29, 2012

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

Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.

FDA root cause category: Error in labeling

What the company is doing

Anspach sent an Urgent Medical Device Labeling Correction letter dated Marach 29,, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the item 18-0079 with their inventory immediately, complete the attached reply form indicating their receipt of the letter. Return the completed form by fax to the number or email provided on the form. If product was further distributed to other facilities, the correction letter should be forwarded to them. Customers with quesitons should call 1-800-327-6887 or email [email protected] or [email protected]. For questions regarding this recall call 561-627-1020.

Recall details

Recall number
Z-0715-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 29, 2012
Posted by the FDA
Jan 10, 2014
Recalling firm
The Anspach Effort, Inc.
Quantity
492 (321 US)
Product code
HBE
FDA submissions
K042783
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.

Product description

Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures

Code information (models, lots, serial numbers)

ALL LOTS for product code 18-0001

Other devices under the same FDA submission

14 devices cleared under K042783 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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