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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.