Disposable Spetzler-Malis Bipolar Forceps Recalled for Incorrect Shelf Life Label
Stryker is recalling 2,321 disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect shelf life. The product label indicates 54 months, but 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 an FDA Class II recall of a surgical instrument due to a shelf-life labeling error. No illnesses or injuries have been reported, but using surgical instruments beyond their intended shelf life constitutes a risk-of-harm scenario that meets the rubric criterion for High severity.
Plain-English summary
Stryker Corporation is recalling 2,321 units of disposable Spetzler-Malis Bipolar forceps (18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005). The affected lot is 200507002 (GTIN: 7613327300192).
An error was identified on the product label. The label indicates a shelf life of 54 months (4.5 years), but the actual shelf life is 36 months (3 years). This discrepancy means products labeled with these incorrect expiration dates could potentially be used beyond their actual shelf life.
The affected products were distributed nationwide in the United States and internationally to Australia, Canada, Japan, Korea, and Singapore. Healthcare facilities and users who have received these products should verify the correct 36-month shelf life and contact Stryker for further guidance.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
- Manufacturer
- Stryker Corporation
- Hazard
- shelf-life-mislabeling
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: 7613327300192
- Lot Numbers: 200507002
Distribution
Distributed nationwide across the United States.
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