Reported Jul 10, 2024 · Ongoing
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 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 NameFathom
- Pedicle-Based Retractor Product NameC/C Blade, 50-80mm
- Model/Catalog NumberMR2102050
- Product DescriptionCranial
- Caudal Blade ComponentYes, a component of a retractor blade
- Lot codes and dates
- UDI10889981300067
- Lot NumberWT36299C
- Amount recalled
- 31 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
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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