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REF MCA5-15SB QTY: 1***1.5 mm Fluted Ball, 5.6 cm. Use… recallZ-2903-2011 · The Anspach Effort, Inc. · initiated Oct 13, 2010

Terminated All recalls posted in August 2011

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

On July 30th, 2010 the Anspach Effort, Inc. initiated a voluntary recall on their Anspach Single Use, Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure.

FDA root cause category: Nonconforming Material/Component

What the company is doing

The Anspach Effort, Inc. sent an "URGENT: MEDICAL DEVICE PRODUCT REMOVAL" letter dated October 20, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customer to screen their inventory for the affected product and not to include any product received after October 18, 2010. Customers are instructed to contact Anspach Customer Support at 800-327-6887 to arrange for return and replacement of product. Customers are to complete and return a Customer Reply Form via fax at 800-327-6661. Questions regarding this notice should be directed to Anspach Customer Support at 800-327-6887. Customer notification began on 10/20/2010 in writing (Fed Ex) with instructions to return the required devices. Anspach utilized their sales representatives to facilitate the product replacement and return activities.

Recall details

Recall number
Z-2903-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 13, 2010
Posted by the FDA
Aug 1, 2011
Recalling firm
The Anspach Effort, Inc.
Quantity
46
Product code
HBE
FDA submissions
K042783
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.

Product description

"***REF MCA5-15SB QTY: 1***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacture The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, Hp 11 1LA United Kingdom Tel: +441494 616126***" "***REF MCA7-15SB QTY: 1***1.5 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacture The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, Hp 11 1LA United Kingdom Tel: +441494 616126***" Cutting and Shaping bone including bones of the spine and cranium

Code information (models, lots, serial numbers)

MCA5-2SD: D163033602, C523029656, and D093032545.  MCA7-2SD: D063031861, D243033598, and D133033340.

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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