Waldemar Link GmbH & Co. KG recall: Endo-Model
Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo-Model – 1 US; 9 OUS. The U.S. Food and Drug Administration published the recall on August 19, 2026; it began on July 6, 2026. Distributed in 1 state (Indiana).
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Endo-Model |
| Brand | Waldemar Link GmbH & Co. KG |
| Company | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 6, 2026 |
| Published by FDA | August 19, 2026 |
| Quantity | 1 US; 9 OUS |
| Recall ID | 99405 |
Recalled products
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- FDA recall number
- Z-2934-2026
- Codes, lots and dates
- UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- Quantity
- 1 US; 9 OUS
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99405
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Norderstedt, Germany
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
1 state: Indiana. Distribution as the FDA records it: “Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99405, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Waldemar Link GmbH & Co. KG Endo-Model recalled?
Yes. Waldemar Link GmbH & Co. KG (Mfg Site) recalled it on July 6, 2026; FDA published it August 19, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it 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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
In 1 state (Indiana).
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.