Device product
Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
Z-1378-2022
Product summary
- Event
- Event 90477
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3785
- Official record key
device-enforcement:Z-1378-2022
Official wording
Reason: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Code information: UDI-DI 04026575034727 X-Small, Right; 04026575034741 Small, Right; 04026575034758 Small, Left; 04026575164042 Medium, Right; 04026575164059 Medium, Left; 04026575164028 Large, Right; Serial/Lot Numbers: 200818/1709 200818/1720 201013/0291 200513/2160 200818/1732 200623/4154 200812/1511 210302/2440
Distribution pattern: Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam
Derived failure modes
-
Unknown
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.