Z-0213-05

Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic...

Name: Z-0213-05 Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic...
Creator: Power Surgical Solutions
Published: 2004-11-03
License: https://open.fda.gov/license/

Medtronic Powered Surgical Solutions / initiated 2004-11-03 / Terminated

FDA source

Power Surgical Solutions began a recall of Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas on 2004-11-03. The reason FDA records is "Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0213-05
Status: Terminated
Initiated: 2004-11-03
Posted: 2004-11-20
Terminated: 2005-11-03
Recalling firm: Medtronic Powered Surgical Solutions
Product: Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas
Product code: HBB Motor, Drill, Pneumatic
Reason for recall: Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).
FDA root cause: Other
Action: The firm initiated the recall by letter on November 3, 2004 asking consignees to return unused units.
Quantity in commerce: 12,286 cases of 4 units per case
Distribution: Product was shipped nationwide and to the following foreign countries: Australia, Canada, Hong Kong, Japan, Netherlands, Columbia, Chile, and Venezuela.
Product codes and lots: A5972-V01; A5982-V01; A5991-V01; A5992-V01; A6308-V01through A6327-V01; A6666-V01 through A6684-V01; A6686-V01 through A6691-V01; A6919-V01 through A6934-V01; A7184-V01 through A7188-V01; A7194-V01through A7198-V01; A7495-V01 through A7501-V01; A7520-V01; A7521-V01; and A7525-V01

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)