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
Reported: July 24, 2024 Initiated: May 22, 2024 #Z-2411-2024
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
Details
- Recalling Firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Units Affected
- 114 units US; 2351 units OUS
- Distribution
- Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand T¿rkiye Ukraine United Arab Emirates United Kingdom Uruguay Vietnam
- Location
- Norderstedt
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Waldemar Link GmbH & Co. KG (Mfg Site). Units affected: 114 units US; 2351 units OUS.
Why was this product recalled? ▼
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2411-2024.
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