Skip to content

Medtronic Midas Rex Legend tapered dissecting tool, Model… recallZ-2156-2008 · Medtronic Powered Surgical Solutions · initiated May 30, 2008

Terminated All recalls posted in August 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Powered Surgical Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2156-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 30, 2008
Posted by the FDA
Aug 23, 2008
Recalling firm
Medtronic Powered Surgical Solutions
Quantity
1,306 units
Product code
HBB
FDA submissions
K020069
Distribution
Nationwide Distribution.

Product description

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.

Code information (models, lots, serial numbers)

Lot numbers: 0000710253, 0000710254, 0000710256, 0000710257, 0000710258, 0000710266, 0000710267, 0000710271, 0000710272, 0000710274, 0000710275, 0000710276, 0000710277, 0000710278, 0000710279, 0000710280, 0000710281, and 0000710288

Other devices under the same FDA submission

109 devices cleared under K020069 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page