Stryker Bipolar Forceps Recalled for Incorrect Expiration-Date Labeling
Stryker Corporation is recalling 2,321 Disposable Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. Products labeled with 54-month shelf life actually have a 36-month shelf life.
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: FDA Class II medical device recall for mislabeled expiration dating. The labeling error represents a risk-of-harm situation where use of expired surgical instruments is possible, but no injuries or adverse events have been reported.
Plain-English summary
Stryker Corporation is recalling Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6770-200-015, 20CM IM DISP BAYONET 1.5MM TIP). The recall affects 2,321 units distributed nationwide in the United States and internationally to Australia, Canada, Japan, Korea, and Singapore.
The product labels contain an error regarding shelf life. The forceps have an actual shelf life of 36 months (3 years), but the labels incorrectly state a shelf life of 54 months (4.5 years). Affected lot numbers are 200731010 and 201008012.
Healthcare facilities and clinics should immediately check their inventory against the lot numbers. Verify the correct expiration dates and do not use affected units beyond their actual 36-month shelf life. Contact Stryker Corporation or your medical device distributor for replacement products and further information.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
- Manufacturer
- Stryker Corporation
- Hazard
- expiration-date-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 (3)
- GTIN: 7613327300352
- Lot Numbers: 200731010
- 201008012
Distribution
Distributed nationwide across the United States.
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