Recall Z-0890-2026 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Waldemar Link GmbH & Co. KG (Mfg Site)
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.
| Date | Dec 9, 2025 (initiated Nov 10, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 18 units |
| Distribution | US distribution to states of: AL, GA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151008 | LINK® MEGASYSTEM-C® Waldemar Link GmbH & Co. KG, Aug 26, 2015 |