FDA recall Z-0239-2024

Stryker Corporation · Class II · device

Product

Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005

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

US Nationwide. Australia, Canada, Japan, Korea, Singapore.

Key facts

Status
Ongoing
Initiation date
2023-09-11
Report date
2023-11-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0239-2024