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
Enforcement
- Recall Number
- Z-2411-2024
- Event ID
- 94814
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- July 24, 2024
- Initiation Date
- May 22, 2024
- Classification Date
- July 18, 2024
- Address
- Oststr. 4-10, Norderstedt, N/A, Germany
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
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Product UDI-DI 16-2817/02 04026575359202; 16-2817/05 04026575359219; 16-2817/07 04026575359226; 16-2817/32 04026575370870; 16-2817/35 04026575370887; 16-2817/37 04026575370894. All product lots manufactured since 01-Jun-2022.
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114 units US; 2351 units OUS