Recall archive
5 recalls · page 1 of 1
Reported Apr 30, 2025
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Globus Medical, Inc.
Matched: Brand — Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm…
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Globus Medical, Inc.
Matched: Brand · Product · Product details — Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
High riskUsing this product could cause serious injury, illness or death — stop using it now.Globus Medical, Inc.
Matched: Brand — A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate…
FDA (openFDA device enforcement)
Reported Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Globus Medical, Inc.
Matched: Brand — Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt…
21 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2013
Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Globus Medical, Inc.
Matched: Brand · Product · Product details — The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
FDA (openFDA device enforcement)
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