Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2673-2020 — 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.

U.S. FDA — Device Enforcement · United States · 2020-06-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2673-2020
Date of alert
2020-06-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Xomed, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0217355465
Reported risk: 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 cosole.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.