—#113406

Product

"***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: 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
510(k) numbers: K011444, K080802
Affected lot / code info: Serial Numbers: E28305271001, E28305271002, E28305271003, E28305271004, E2830527100, E28305271006, E28305271007, E28305271008, E2830521009, E28305271010, E29305270901, E29305270902, E29305270903, E29305271101, E29305271102, E29305271103, E29305271104, E29305271105, E29305271106, E29305271107, E29.

Why it was recalled

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.

Timeline

Recall initiated: 2012-01-09
Posted by FDA: 2012-10-18
Terminated: 2014-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113406. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.