Endo-Model — Class II medical device recall Z-2934-2026
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2026-08-19, distributed in IN. The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge
| Recall number | Z-2934-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, Germany |
| Recall initiated | 2026-07-06 |
| Classified | 2026-08-11 |
| Reported by FDA | 2026-08-19 |
| Distributed | IN |
| Countries outside the US | DE |
| UPC / GTIN / UDI-DI | 04026575432134 |
| Model numbers | 15-0027/16, 2604069 |
Product
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2934-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.