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The DIXI Medical Microdeep Depth Electrode (Microdeep Depth… recallZ-0538-2022 · Dixi Medical USA · initiated Dec 9, 2021

Terminated

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 Dixi Medical USA 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

Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

FDA root cause category: Under Investigation by firm

What the company is doing

Dixi Medical issued Urgent Medical Device Letter on 12/9/21. Letter states reason for recall, health risk and action to take: 1. Examine your inventory for the affected product. Any available stock must be quarantined immediately and placed in a secure location to prevent further usage. 2. Please use the response form to record and return the stock back to the manufacturer. 3. The returned stock will be replaced with compliant products. 4. Please complete and return the attached Customer Response Form to Ann Cirner, [email protected] (248)845-3494, even if you do not have affected product on hand. 5. Please forward this information to all your staff that may use the MICRODEEP during a SEEG procedure in your healthcare facility. 6. If you have further distributed the product, please forward this notification to any downstream accounts. The removal and return of affected products will be carried out by the hospital staff. Your assistance is appreciated and necessary to prevent a potential patient harm. If you have any questions, call Ann Cirner, [email protected] (248)845-3494

Recall details

Recall number
Z-0538-2022
Status
Terminated
Initiated by the company
Dec 9, 2021
Recalling firm
Dixi Medical USA
Quantity
3548 units
Product code
GZL
FDA submissions
K170959
Distribution
US Nationwide distribution.

Product description

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

Code information (models, lots, serial numbers)

All lots UDI:03664539000091

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

11 devices cleared under K170959 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 89306).

Sources and updates

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