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 Recall Z-0083-2010 · Posted 2009-10-28
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Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHBE
Date Initiated2009-08-13
Date Terminated2010-01-05
Product Quantity14
Reason for Recall
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
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- Canada, Indonesia, United Kingdom, Korea and United States (NC, OK, TN, CA, KS, MI and WA).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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