FDA Enforcement
Class II
Ongoing
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010
Recall: Z-0246-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0246-2024
- Event ID
- 93211
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- September 11, 2023
- Classification Date
- November 7, 2023
- Address
- 1941 Stryker Way, Portage, MI, 49002-9711, United States
Description
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010
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 Info
GTIN: 7613327300260; Lot Numbers: 200515007, 200731007, 200924011, 201001028
Distribution
US Nationwide. Australia, Canada, Japan, Korea, Singapore.
Quantity
2,321 total units