Z-2156-2008

Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions...

Name: Z-2156-2008 Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions...
Creator: Medtronic Powered Surgical Solutions
Published: 2008-05-30
License: https://open.fda.gov/license/

Medtronic Powered Surgical Solutions / initiated 2008-05-30 / Terminated / root cause: manufacturing process

FDA source

Medtronic Powered Surgical Solutions began a recall of Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial... on 2008-05-30. The reason FDA records is "Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and...". 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-2156-2008
Status: Terminated
Initiated: 2008-05-30
Posted: 2008-08-23
Terminated: 2009-08-22
Recalling firm: Medtronic Powered Surgical Solutions
Product: Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.
Product code: HBB Motor, Drill, Pneumatic
Reason for recall: Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Firm notified consignees by Urgent: Medical Device Recall letter sent May 30, 2008. The letter requires consignees to immediately compare their inventory of products against the list provided and quarantine any unused dissecting tools. The letter also states that Medtronic would provide replacement product to match the quantity and type returned by the consignees' institution.
Quantity in commerce: 1,306 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot numbers: 0000710253, 0000710254, 0000710256, 0000710257, 0000710258, 0000710266, 0000710267, 0000710271, 0000710272, 0000710274, 0000710275, 0000710276, 0000710277, 0000710278, 0000710279, 0000710280, 0000710281, and 0000710288

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)