Recall Z-2411-2024— Waldemar Link GmbH & Co. KG (Mfg Site)
Class II · Ongoing
Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2024-05-22. It names 3 FDA 510(k) clearances: K212742, K151008, K143179. Product: Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm. Reason: Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique.
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-22
- Firm location
- Norderstedt, Germany
510(k) clearances named in this recall
3 on FDA's record- K212742 — GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
- K151008 — LINK® MEGASYSTEM-C®
- K143179 — The LINK® Endo-Model® Knee System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm
Reason for recall
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Data sourced from openFDA. This site is unofficial and independent of the FDA.