Recall Z-2934-2026 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
| Date | Aug 11, 2026 (initiated Jul 6, 2026) |
| Status | Open, Classified |
| Reason | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant. |
| Root cause | Process change control |
| Action | Foreign manufacturer, Waldemar Link GmbH & Co KG, notified importer LinkBio Corp. on 7/6/2026 via email. LinkBio then notified the single US consignee by email/Docusign on 7/7/2026. Customer was instructed to return the affected product to LinkBio. |
| Quantity | 1 US; 9 OUS |
| Distribution | Domestic US distribution to Indiana. OUS distribution to Belarus and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143179 | The LINK® Endo-Model® Knee System Waldemar Link GmbH & Co. KG, Jan 30, 2015 |