Z-0244-2024 Class II Ongoing

Recalled by Stryker Corporation — Portage, MI

FDA device recall Z-0244-2024 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, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015

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: 7613327300246; Lot Numbers: 200507009