Z-1033-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2023
- Initiation Date
- November 17, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216 units
Product Description
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of AR, MD, WA, WI.
Code Information
Item Number: DYNJ908295, UDI/GTIN Case: 40195327029570, UDI/GTIN Each: 10195327029579, Lot Numbers: 22IBN449, 22JBQ931