Recall Z-1474-2011 ยท HBC Motor, Drill, Electric
Aesculap Inc
Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro and Maxillo facial Surgery.
| Date | Mar 2, 2011 (initiated Nov 22, 2010) |
| Status | Terminated |
| Reason | Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion. |
| Root cause | Software design |
| Action | AESCULAP sent an IMPORTANT CORRECTION NOTICE letter dated November 22, 2010, to all affected consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to not use the motors for thread cutting and removal of screws. If any unusual reactions of any cutting tools were observed consignees should check to ensure that the motor is not running in the opposite direction. If any error message is displayed, consigness were instructed to not use the motor. Consignees were also instructed to check both directions of running before us |
| Quantity | 91 units |
| Distribution | Worldwide Distribution - USA including CA, CO, DE, FL, GA, IN, LA, MO, NC, NJ, OK, PA, TN, TX, and VA and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053526 | MICROSPEED UNI MOTOR SYSTEM Aesculap, Inc., Jan 18, 2006 |