Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
- Recall Initiated
- November 10, 2025
- Posted
- December 9, 2025
- Recall Number
- Z-0890-2026
- Quantity
- 18 units
Reason for Recall
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
Distribution
US distribution to states of: AL, GA, and TX.
Lot / Code Info
Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
Root Cause
Process control
Action Taken
On November 10, 2025, URGENT: MEDICAL DEVICE RECALL letters were emailed to distributors. Actions to be taken: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.