—#104169

Product

"***REF GRE-1***1.85 mm x 16 mm Fluted Router. Use with B-GREEN Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: 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, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: B053003318. Product Usage: Cutting and shaping bone including bones of the spine and cranium.

FDA product code: HTT — Burr, Orthopedic
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K802598
Affected lot / code info: Lot number: B053003318.

Why it was recalled

The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.

Root cause (FDA determination)

Employee error

Action the firm took

The firm, Anspach sent an "URGENT PRODUCT REMOVAL" letter on May 29, 2008, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for all products listed on the attached "Product Replacement Form." Upon visual inspection if the pouch is sealed on both ends it is sterile. If one end of the pouch is not sealed it is non-sterile and should be returned for credit or replacement. 2) Complete the "Product Replacement Form" by indicating the quantity returned, and whether the customer would prefer to have their returned devices replaced, or their account credited. 3) Place products to be returned in a box and mark the box with the Return Authorization Number on the "Product Replacement Form." 4) Use the Anspach FedEx account number listed on the form to return the unused devices with the completed "Product Replacement Form." Following receipt of the form, Anspach will process the request immediately. For questions related to the product replacement, please contact Customer Service at 800-327-6887. For questions related to the Voluntary Removal, please contact Anspach Regulatory Affairs and Quality Assurance at 800-327-6887.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including the states of: CA, CO, FL, GA, IA, ID, SC, MA, MD, MI, MO, MN, MS, NY, OH, OR, PA, TN, TX, and WI, and the countries of: Africa, Netherlands, Panama, South Korea, Spain, and United Kingdom.

Timeline

Recall initiated: 2008-05-19
Posted by FDA: 2011-10-21
Terminated: 2011-10-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104169. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.