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Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only recallZ-0566-2018 · Medtronic Sofamor Danek USA Inc · initiated Dec 22, 2017

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 Medtronic Sofamor Danek USA Inc 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

Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.

FDA root cause category: Process control

What the company is doing

The firm initiated the recall by letter on 12/22/2017, requesting the return of the product.

Recall details

Recall number
Z-0566-2018
Status
Terminated
Initiated by the company
Dec 22, 2017
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
2 units
Product code
MDM
Distribution
MN, NC

Product description

Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only

Code information (models, lots, serial numbers)

UDI: 00643169363502, Lot Number EM17F015

Devices named in this recall

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

Sources and updates

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