Z-1080-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2023
- Initiation Date
- November 17, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 cases (104 units)
Product Description
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Code Information
a. UNIVERSAL PLASTIC, Item Number: DYNJ04047C, Case UDI/GTIN: 40888277855060, Unit UDI/GTIN: 10888277855069, Lot Number: 22IBH860,22IBJ054; b. KNEE ARTHROSCOPY PACK, Item Number: DYNJ24784C, Case UDI/GTIN: 40889942732587, Unit UDI/GTIN: 10889942732586, Lot Number: 22JBM001;