Company: Medtronic Xomed, Inc.
Date of Enforcement Report: 7/29/2020
Class II

PRODUCT

Software 1898072 IPC upgrade v 2.7.3.0 – Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.

Recall Number: Z-2673-2020

REASON

During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the console.

RECALLING FIRM/MANUFACTURER

Medtronic Xomed, Inc. on 6/12/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

673 units

DISTRIBUTION

U.S. Nationwide and International