Home / Recalls / Waldemar Link GmbH & Co. KG (Mfg Site) / Z-2411-2024

Z-2411-2024 Class II Ongoing

Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) — Norderstedt

FDA device recall Z-2411-2024 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on May 22, 2024 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 114 units US; 2351 units OUS.

Recall Details

Product Type: Devices
Report Date: Jul 24, 2024
Initiation Date: May 22, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 114 units US; 2351 units OUS

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

Distribution Pattern

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

Code Information

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.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2411-2024
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.