—#101661

Product

***REF MCA5-06SD, QTY: 1***0.6 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***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 MCA7-06SD, QTY: 1***0.6 mm Diamond Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***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

FDA product code: HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class: Class 2
Medical specialty: Neurology
Affected lot / code info: MCA5-2SD: D163033602, C523029656, and D093032545. MCA7-2SD: D063031861, D243033598, and D133033340. MCA5-06SD: C523029655, D143032967, D093032546. MCA7-06SD: C523029657.

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.

Timeline

Recall initiated: 2010-10-13
Posted by FDA: 2011-08-01
Terminated: 2011-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101661. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.