Device product
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
Z-1080-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26 cases (104 units)
- Official record key
device-enforcement:Z-1080-2023
Official wording
Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
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;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Derived failure modes
-
Unknown
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.