—#84580

Product

Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP. Indicated to cut and shape 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: EMAX2-FP Serial Numbers: C26302250301, C26302250302, C26302250303, C26302250304, 5044044307, 31495607, 32380602, 31832209, 31832202 and 32366805; and EPLUS-FP Serial Numbers: C26302200804 , C26302200802, C27302221701 and C08301701901.

Why it was recalled

The Anspach Effort, Inc. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield connection from the cable to the connector body. The lack of shielding may result in radiated emissions which could possibly cause interference on other electrical equipment adjacent to the foot pedal

Root cause (FDA determination)

Device Design

Action the firm took

Anspach issued an "Urgent Product Removal" Letter dated August 17, 2009 informing customers of the affected product. Consignees are asked to screen their inventory and return any affected product including a completed Product Replacement Form to the firm. For further questions, contact Anspach at 1-800-327-6887 or 1-561-627-1080.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- Canada, Indonesia, United Kingdom, Korea and United States (NC, OK, TN, CA, KS, MI and WA).

Timeline

Recall initiated: 2009-08-13
Posted by FDA: 2009-10-28
Terminated: 2010-01-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84580. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.