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MIDAS REX LEGEND

MEDTRONIC POWERED SURGICAL SOLUTIONS · Model AS10S · UDI-DI 00763000440480

HBB Prescription

510(k) clearances

9,613

Adverse events (4 deaths)

Recalls

Facilities

Description

ATT AS10S LEGEND 10CM STRA SH 9ST 2.4MM

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 (OUS).
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 of the motor. There
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 control, without a pre
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 requirements.
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 requirements.
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 requirements.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.