Reported Feb 14, 2024 · Ongoing
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
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?
- ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
- Lot codes and dates
- UDI-DI 00889095998498 Lots
FSB136AAFSB121AAFSB241AAFSB207AAFSB136AAFSB121AAFSB110AAFSB073AAFSA286CAFSA286BAFSA286AAFSA263DAFSA263EAFSA263CAFSA263AAFSA263BAFSA160AAFSA160BAFSA105BAFSA105AAFSA053AAFSY319AAFSY279BAFSY279AAFSY272AAFSY230AAFSY098AAFSY098CAFSY098BAFSY048AAFSX093AAFSX205AAFSX141BAFSX141CAFSX141AAFSX093AAFSX063AAFSX041AAFSX041BAFSW142AAFSW094AA
- UDI-DI 00889095998498 Lots
- Amount recalled
- 570
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination.
This product could cause temporary or reversible health problems — stop using it.
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