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Recall Observatory FDA recall evidence

Device product

Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010

Z-0253-2024

September 11, 2023

Class II

Product summary

Firm
Stryker Corporation
Event
Event 93211
Status
Ongoing
Classification
Class II
Quantity
2,321 total units
Official record key
device-enforcement:Z-0253-2024

Official wording

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 product label represents a 54 month (4.5 year) shelf life.

Code information: GTIN: 7613327300369; Lot Numbers: 200525011, 200806012, 201015015

Distribution pattern: US Nationwide. Australia, Canada, Japan, Korea, Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.