FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1474-2011
- Recalling firm
- Aesculap Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-11-22
- Posted
- 2011-03-02
- Terminated
- 2012-07-05
- 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 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.
- 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.
- Lot, serial or model codes
- Part #GD670 - all distributed lot numbers and serial numbers
- 510(k) numbers
- ["K053526"]
- PMA numbers
- not on file
- Product code
- HBC
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28