FDA Device recall Z-1380-2022
Tibial Component Modular. orthopedic prosthesis
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Tibial Component Modular. 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-1380-2022 |
| 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
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
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: 04026575370870 Small, W; 04026575370887 Medium, W; 04026575370894 Large, W; Serial/Lot Numbers: 210308…UDI-DI: 04026575370870 Small, W; 04026575370887 Medium, W; 04026575370894 Large, W; Serial/Lot Numbers: 210308/0020 210308/0035 210222/0789 151116/4741 |
|---|
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-1380-2022%22
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