FDAFDA · Food and drugs·Recall number Z-2871-2020
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
Published September 2, 2020 · Recall initiated: July 22, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Globus Medical, Inc.
- Distributor
- Worldwide Distribution
- Lot
- Part #: 1124.1235; Lot # / UDI #: BAX103WE / (01)00889095069976(10)BAX103WE; BAX227VE / (01)00889095069976(10)BAX227VE
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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