—#124873

Product

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

FDA product code: HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K042783
Affected lot / code info: ALL LOTS for product code 18-0001

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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 customer.support@synthes.com or ProductSupportTeam@Synthes.com. For questions regarding this recall call 561-627-1020.

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 Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.

Timeline

Recall initiated: 2012-03-29
Posted by FDA: 2014-01-10
Terminated: 2017-10-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124873. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.