Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
Brand
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
Lot Codes / Batch Numbers
UDI-DI 04026575034727 X-Small, Right, 04026575034741 Small, Right, 04026575034758 Small, Left, 04026575164042 Medium, Right, 04026575164059 Medium, Left, 04026575164028 Large, Right
Products Sold
UDI-DI 04026575034727 X-Small, Right; 04026575034741 Small, Right; 04026575034758 Small, Left; 04026575164042 Medium, Right; 04026575164059 Medium, Left; 04026575164028 Large, Right; Serial/Lot Numbers: 200818/1709 200818/1720 201013/0291 200513/2160 200818/1732 200623/4154 200812/1511 210302/2440
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany is recalling Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-38 due to There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Recommended Action
Per FDA guidance
On May 24, 2022, the firm notified affected customers via Urgent Field Safety Notice email. Customers were provided a modified surgical technique providing information for the cementing technique for Tilastan proximal spacers to minimize the risk. No product return is required.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA
Page updated: Jan 10, 2026