Reported Sep 2, 2020 · Terminated
ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
Globus Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Globus Medical, Inc. · 2560 General Armistead Ave · Audubon, PA · 19403-5214
Is this the product you have?
ALTERA Spacer ALTERA Spacer10x368-12mm8¿
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 1124.1211 2 00889095069877Lot # / UDI #: BAX103VE / (01)00889095069877(10)BAX103VE 3 00889095069877BAX109ME / (01)00889095069877(10)BAX109ME 4 00889095069877BAX203PE / (01)00889095069877(10)BAX203PE 5 00889095069877BAX315BE / (01)00889095069877(10)BAX315BE 6 00889095069877BAX359ME / (01)00889095069877(10)BAX359ME 7 00889095069877BAX412WE / (01)00889095069877(10)BAX412WE - Amount recalled
- N/A
This recall covers 22 products
The agency filed one notice per product. You are reading one of them; the other 21 are below.
9 more are in the archive.
Why it was recalled
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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