FDA Medical devices recall ·
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE… recall
- Recall number
- Z-2934-2026
- Date
- (initiated July 6, 2026)
- Company / brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
Ost Str. 4-10, Norderstedt, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 US; 9 OUS
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
Distribution
Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
States: Indiana
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2934-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.