Curved, super elastic cement delivery needle that passes through the cannula in a straight config...
FDA Recall #Z-2260-2024 — Class II — June 3, 2024
Product Description
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point of access in the patient. Catalog Number: 1025-011-500
Reason for Recall
Expired Products distributed to customers
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 units
Distribution
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Code Information
GTIN: 07613327374629 Lot Number: 6659783
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated