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Medtronic Midas Rex Legend Footed Attachment, AF01 recallZ-0546-2010 · Medtronic Sofamor Danek Usa, Inc - Dallas Distribution · initiated Nov 30, 2009

Terminated All recalls posted in December 2009

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 Sofamor Danek Usa, Inc - Dallas Distribution 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

Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0546-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 30, 2009
Posted by the FDA
Dec 17, 2009
Recalling firm
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Quantity
64
Product code
HBB
FDA submissions
K020069
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 description

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.

Code information (models, lots, serial numbers)

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.

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

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