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Recall Observatory FDA recall evidence

Device product

Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015

Z-0247-2024

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-0247-2024

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: 7613327300321; Lot Numbers: 200515008, 200525009, 200626006, 200731008, 200806007

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.