Device product
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Z-2604-2023
Product summary
- Event
- Event 92969
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-2604-2023
Official wording
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Code information: UDI-DI/Lot/Expiration: 00888912076210/878B1171/May 2, 2027
Distribution pattern: US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany
Derived failure modes
-
Unknown
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery