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.
FDA Recall Z-1474-2011 · Posted 2011-03-02
Recalling FirmAesculap Inc
Recall StatusTerminated
Product CodeHBC
Date Initiated2010-11-22
Date Terminated2012-07-05
Product Quantity91 units
Reason for Recall
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.
Firm 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 use and do not use a motor which produces an error message in one direction.
Aesculap would be providing all customers with a software update to the MicroSpeed Uni control box either by the unit being returned to Aesculap for update or by firm representative doing the upgrade on site at their facility.
For questions regarding this recall call 800-258-1946 x5254 or 800-258-1946 x5267.
Root Cause
Software design
Distribution Pattern
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.
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.