Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Endo Model SL Tibial Components 16-2817/02 Tibial Component Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) Due to Blind screws of the modular tibial component cannot...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Waldemar Link GmbH & Co. KG (Mfg Site) directly.
Affected Products
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
Quantity: 114 units US; 2351 units OUS
Why Was This Recalled?
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Waldemar Link GmbH & Co. KG (Mfg Site)
Waldemar Link GmbH & Co. KG (Mfg Site) has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report