Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-23...
FDA Recall #Z-0250-2024 — Class II — September 11, 2023
Product Description
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
Reason for Recall
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2,321 total units
Distribution
US Nationwide. Australia, Canada, Japan, Korea, Singapore.
Code Information
GTIN: 7613327300161; Lot Numbers: 200515009, 201008013, 201015011, 201126013
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated