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Recall Observatory FDA recall evidence

Device product

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

Z-0566-2018

December 22, 2017

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 78839
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0566-2018

Official wording

Reason: 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.

Code information: UDI: 00643169363502, Lot Number EM17F015

Distribution pattern: MN, NC

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.