Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
Lot Codes / Batch Numbers
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.
Products Sold
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.
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany is recalling Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817 due to Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, pro. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Recommended Action
Per FDA guidance
LinkBio issue Urgent Medical Device Correction letter to Distributors via email on June 10, 2024. Letter states reason for recall, health risk and action to take: Please take note of the attached modified Surgical Technique for cementing the Tilastan Proximal Tibial Spacer or Proximal Tibial Segment, provided in Appendix A of this notice. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to apply the provided cementing surgical technique for the Tilastan Proximal Tibial Spacer or Proximal Tibial Segment, in case the blind screws are unable to be removed. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions
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 noticePage updated: Jan 10, 2026