Home › Device types › HBB

Motor, Drill, Pneumatic

FDA product code HBB · Class 2 · Neurology

2,161

Registered devices

9,613

Adverse events

Recalls

510(k) clearances

Devices with this code

Recent recalls

Date	Firm	Reason
2025-08-18	Aesculap AG	Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
2025-08-18	Aesculap AG	Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
2017-09-01	Aesculap Implant Systems LLC	The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States
2016-04-28	Stryker Instruments Div. of Stryker Corporation	Due to the buildup of grease within the hose and motor, the product may require multiple attempts to start. The grease may also migrate into the attachment end
2016-04-08	Medtronic Sofamor Danek Usa, Inc - Dallas Distribution	Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
2015-10-21	Medtronic Sofamor Danek Usa, Inc - Dallas Distribution	The wire pass hole is not present on the tools.
2013-04-25	The Anspach Effort, Inc.	The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot co
2012-11-28	The Anspach Effort, Inc.	The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System
2012-11-28	The Anspach Effort, Inc.	The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System
2012-11-28	The Anspach Effort, Inc.	The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.