Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Compone

Recalled July 24, 2024 · FDA recall Z-2411-2024 · Waldemar Link GmbH & Co. KG (Mfg Site)

Hazard

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique · FDA Class II

Units

114 units US; 2351 units OUS

Sold at

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

Description

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

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

Manufacturer(s)

Waldemar Link GmbH & Co. KG (Mfg Site)

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →