Endo-Model Standard Knee Prosthesis System recallZ-2934-2026 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Jul 6, 2026
Class II Open, Classified All recalls posted in August 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-2934-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 6, 2026
- Posted by the FDA
- Aug 11, 2026
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 1 US; 9 OUS
- Product code
- KRO
- FDA submissions
- K143179
- Distribution
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
Product description
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Code information (models, lots, serial numbers)
UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Endo-Model Standard Knee Prosthesis System 15-0027/16WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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