Recall Z-1523-2026 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
| Date | Mar 10, 2026 (initiated Jan 12, 2026) |
| Status | Open, Classified |
| Reason | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Root cause | Under Investigation by firm |
| Action | On or about January 12, 2026 URGENT FIELD SAFETY NOTICE Product Recall letters were sent to customers. Actions to be taken: Review inventory to identify and quarantine any affected product. Return any unused product to the manufacturer. Follow patient management recommendations, if implanted. A custom-made replacement set can be requested. If an affected product is noticed during implantation, another plateau screw from a replacement set or different LINK knee prosthesis package can be used. If this situation occurs, a complaint form must be completed and sent to Complaint@link-ortho.com. Th |
| Quantity | 3 units (OUS only) |
| Distribution | Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. |
| 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 |