Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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

U.S. FDA — Device Enforcement · United States · 2024-05-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2235-2024
Date of alert
2024-05-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
SEASPINE ORTHOPEDICS CORPORATION
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10889981300067
Reported risk: Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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