Reported Jul 24, 2024 · Ongoing
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product…
Seaspine Orthopedics Corporation
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: SEASPINE ORTHOPEDICS CORPORATION · 5770 Armada Dr · Carlsbad, CA · 92008-4608
Is this the product you have?
- Brand NameMeridian
- Angled Awl Fixed Product NameAngled
- Awl Fixed Model/Catalog NumberRA2-003015
- Product DescriptionSurgical
- Awl ComponentNo
- Lot codes and dates
- Lot Code
UDI 10889981216368 Lot Numbers TT0190HTT0191H
- Lot Code
- Amount recalled
- 100 units
Where it was sold
Why it was recalled
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
This product could cause temporary or reversible health problems — stop using it.
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