Recall Z-0083-2010 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
The Anspach Effort, Inc.
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.
| Date | Oct 28, 2009 (initiated Aug 13, 2009) |
| Status | Terminated |
| Reason | 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 | Device Design |
| 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. |
| Quantity | 14 |
| Distribution | Worldwide Distribution -- Canada, Indonesia, United Kingdom, Korea and United States (NC, OK, TN, CA, KS, MI and WA). |
| FDA record | Open on fda.gov |