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

FDA Recall #Z-0566-2018 — Class II — December 22, 2017

Recall #Z-0566-2018 Date: December 22, 2017 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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.

Recalling Firm

Medtronic Sofamor Danek USA Inc — Memphis, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2 units

Distribution

MN, NC

Code Information

UDI: 00643169363502, Lot Number EM17F015

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated