FDA Device recall Z-1378-2022
Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis by Waldemar Link And Kg Mfg Site, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1378-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-24 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA |
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.
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.
Identifiers
| code_info | UDI-DI 04026575034727 X-Small, Right; 04026575034741 Small, Right; 04026575034758 Small, Left; 04026575164042 Medi…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1378-2022%22
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