FDA recall, , Moderate risk
Waldemar Link Endo-Model Tibial Plateau Replacement Sets
The Endo-Model replacement set for a tibial plateau incorrectly contains a Pure Hinge plateau, which could lead to prolonged surgery or implant wear.
Summary by Recall Canary from the FDA notice
What happened
Waldemar Link GmbH & Co. KG, based in Norderstedt, Germany, recalled its Endo-Model Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16. The affected set 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.
The company began the recall on July 6, 2026, and the FDA added it to its Enforcement Report on August 11, 2026. Domestic distribution was to Indiana, with OUS distribution to Belarus and Germany.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
Affected if its UDI-DI or item number is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe, CoCrMo, Rotating Hinge Item Number 15-0027/16
- UDI-DI
- 04026575432134
- Recall number
- Z-2934-2026
- Item number
- 15-0027/16
Recall details
- Company began the recall
- Sold in
Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Company
- Waldemar Link GmbH & Co. KG (Mfg Site)Norderstedt, Germany
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99405
- Recall number
- Z-2934-2026
- Quantity recalled
- 1 US; 9 OUS
All recalls from Waldemar Link GmbH & Co. KG (Mfg Site)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
