Z-0246-2024 Class II Ongoing
FDA device recall Z-0246-2024 was initiated by Stryker Corporation on September 11, 2023 and is designated Class II. Reason for recall: 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 li… The recall status is ongoing. Affected quantity: 2,321 total units.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- September 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,321 total units
Product Description
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010
Reason for Recall
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.
Distribution Pattern
US Nationwide. Australia, Canada, Japan, Korea, Singapore.
Code Information
GTIN: 7613327300260; Lot Numbers: 200515007, 200731007, 200924011, 201001028