Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005
Summary
The FDA issued a Class II for Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog by Stryker Corporation. Reason: 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 produ.
Details
Source
Device Recall
External ID
Z-0252-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005
Lot/Code Info: GTIN: 7613327300277; Lot Numbers: 201008016, 201015014, 201029008, 201210016
Quantity Affected: 2,321 total units
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.
Distribution
US Nationwide. Australia, Canada, Japan, Korea, Singapore.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-11
Company
Portage, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Corporation have FDA actions?
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0252-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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