FDA Device recall Z-2934-2026
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- FDA Device
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 by Waldemar Link And Kg Mfg Site, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2934-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-06 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | IN |
Product
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
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.
Identifiers
| code_info | UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2934-2026%22
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