FDAFDA · Food and drugs·Recall number Z-2235-2024
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
Published July 10, 2024 · Recall initiated: May 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Distributor
- United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
- Lot
- UDI: 10889981300067 Lot Number: WT36299C
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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