FDA recall Z-0287-2024

Product

Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.

Reason for recall

Expired product distributed

Distribution

US: NH, TX, NY, NJ, OH, MN OUS: None

Key facts

Status

Ongoing

Initiation date

2023-09-13

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0287-2024