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