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
- Recall Number
- Z-0890-2026
- Event Number
- 97971
- Firm
- Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
- FEI Number
- 3003386935
- Product Code
- KRO
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 10, 2025
- Posted
- December 9, 2025
Description
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.
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.
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 [email protected] for any questions.
US distribution to states of: AL, GA, and TX.
18 units