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MIDAS REX LEGEND

MEDTRONIC POWERED SURGICAL SOLUTIONS · Model T17MH30D · UDI-DI 00763000463441

HBB Prescription
2
510(k) clearances
9,613
Adverse events (4 deaths)
18
Recalls
45
Facilities

Description

TOOL T17MH30D LGND 17CM 3MM MATCH D TLSC

Recalls

DateFirmReason
2025-08-18Aesculap AGMislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
2025-08-18Aesculap AGMislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
2017-09-01Aesculap Implant Systems LLCThe 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).
2016-04-28Stryker Instruments Div. of Stryker CorporationDue 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
2016-04-08Medtronic Sofamor Danek Usa, Inc - Dallas DistributionIncorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
2015-10-21Medtronic Sofamor Danek Usa, Inc - Dallas DistributionThe wire pass hole is not present on the tools.
2013-04-25The 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
2012-11-28The 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.
2012-11-28The 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.
2012-11-28The 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.