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Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge… recallZ-0213-05 · Power Surgical Solutions · initiated Nov 3, 2004

Terminated All recalls posted in November 2004

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 Power 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

Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).

FDA root cause category: Other

What the company is doing

The firm initiated the recall by letter on November 3, 2004 asking consignees to return unused units.

Recall details

Recall number
Z-0213-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 3, 2004
Posted by the FDA
Nov 20, 2004
Recalling firm
Power Surgical Solutions
Quantity
12,286 cases of 4 units per case
Product code
HBB
FDA submissions
K020069
Distribution
Product was shipped nationwide and to the following foreign countries: Australia, Canada, Hong Kong, Japan, Netherlands, Columbia, Chile, and Venezuela.

Product description

Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas

Code information (models, lots, serial numbers)

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

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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