Z-0287-2024 Class II Ongoing
FDA device recall Z-0287-2024 was initiated by Stryker Corporation on September 13, 2023 and is designated Class II. Reason for recall: Expired product distributed The recall status is ongoing. Affected quantity: 19 kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- September 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 kits
Product Description
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 Pattern
US: NH, TX, NY, NJ, OH, MN OUS: None
Code Information
Lot # 007047/UDI: 07613252632863