Stryker Disposable Spetzler-Malis Bipolar Forceps Expiration Date Mislabeled
Stryker Corporation recalled disposable surgical forceps with mislabeled expiration dates. The product label incorrectly indicates a 54-month shelf life when the actual shelf life is 36 months.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving mislabeled expiration dating with potential risk of harm from using surgical instruments beyond their actual shelf life. No illnesses or injuries have been reported, and the hazard remains theoretical.
Plain-English summary
Stryker Corporation is recalling Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP (Catalog Number 6760-200-005), due to an expiration date labeling error. The product label states a shelf life of 54 months (4.5 years), but the actual shelf life is 36 months (3 years).
The recall affects 2,321 units distributed in the United States, Australia, Canada, Japan, Korea, and Singapore. Lot number 201105002 is involved.
The labeling error means surgical facilities using this lot number may unknowingly use devices beyond their actual approved shelf life. No illnesses or injuries have been reported.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005
- Manufacturer
- Stryker Corporation
- Affected units
- 2,321
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: 7613327300284
- Lot Numbers: 201105002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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