FDA Device recall Z-1379-2022
Tibial Component. 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. 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-1379-2022 |
| 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. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
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: 04026575359202 Small, W; 04026575359219 Medium, W; 04026575359226 Large, W; Serial/Lot Numbers: 2010…UDI-DI: 04026575359202 Small, W; 04026575359219 Medium, W; 04026575359226 Large, W; Serial/Lot Numbers: 201002/1683 211025/1543 210202/0275 210302/0308 210314/1872 201002/1687 |
|---|
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-1379-2022%22
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