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 Initiated
- May 22, 2024
- Posted
- July 18, 2024
- Recall Number
- Z-2411-2024
- Quantity
- 114 units US; 2351 units OUS
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
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
Lot / Code Info
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.
Root Cause
Process design
Action Taken
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