Device product
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
Z-1033-2023
Product summary
- Event
- Event 91387
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 216 units
- Official record key
device-enforcement:Z-1033-2023
Official wording
Reason: Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Code information: Item Number: DYNJ908295, UDI/GTIN Case: 40195327029570, UDI/GTIN Each: 10195327029579, Lot Numbers: 22IBN449, 22JBQ931
Distribution pattern: US Nationwide distribution in the states of AR, MD, WA, WI.
Derived failure modes
-
Unknown
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.