Z-0546-2010

Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors...

Name: Z-0546-2010 Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors...
Creator: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Published: 2009-11-30
License: https://open.fda.gov/license/

Medtronic Powered Surgical Solutions / initiated 2009-11-30 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution began a recall of Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial... on 2009-11-30. The reason FDA records is "Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0546-2010
Status: Terminated
Initiated: 2009-11-30
Posted: 2009-12-17
Terminated: 2010-05-12
Recalling firm: Medtronic Powered Surgical Solutions
Product: Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.
Product code: HBB Motor, Drill, Pneumatic
Reason for recall: Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic issued an "Urgent: Medical Device Recall" letter dated November 30, 2009. Consignees were notified of the issued and asked to quarantine any affected product and return affected product to the firm for replacement. For further information, contact Medtronic Powered Surgical Solutions Customer Service at 1-800-433-7080 or 1-817-788-6400.
Quantity in commerce: 64
Distribution: Worldwide Distribution -- Including the United States (DC, TN, NC, KY, AL, FL, NJ, OH, MI, IN, NY, WA, CA, NV, NM, IA, MO, NE and UT), Great Britain, Brazil, Turkey, Singapore and the Netherlands.
Product codes and lots: Serial Numbers: A3275-03, A7094-01, B1536-06, B1536-07, B3532-02, B8465-09, C3472-08, C7120-02, C7255-01, D1646-02, D1972-01, D1972-04, D2604-01, D2604-04, D4212-05, D5683-03, D6441-01, D6504-05, P00197407, P00204906, P00360920 - P00360924, P00363252 - P00363256, P00364049 - P00364052, P00365059 - P00365061, P00365786 - P00365792, P00365794, P00365799, P00365800, P00368100 - P00368103, P00369724 - P00369726, P00369728, P00372167 - P00372171, T-1035-07, T2648-02, T3188-06 and T5016-02.

Product code HBB

K020069Class IIMedtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend SystemMedtronic Midas Rex / cleared 2002-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)