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Endo-Model Tibial Plateau Replacement Set
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MEDICAL DEVICE RECALLMODERATE

Endo-Model Tibial Plateau Replacement Set

Waldemar Link recalls Endo-Model tibial plateau replacement sets that may contain the wrong hinge component.

What to do

Contact Waldemar Link or your healthcare provider to verify whether your replacement set is affected and to arrange for a correct replacement. Do not use the set if it contains a Pure Hinge plateau instead of the Rotating Hinge plateau.

Recalled
Listed
Updated
Recall No.
Z-2934-2026
Agency
FDA
Firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Recall ID
99405
Status
ONGOING

Recall at a glance

Quantity recalled
1 US; 9 OUS

Why it was recalled

Waldemar Link is recalling the Endo-Model Replacement Set for a Rotating Hinge tibial plateau because it incorrectly contains a Pure Hinge plateau. The wrong component can prolong or modify surgery, and if implanted, may increase wear and reduce the implant's standing time.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

UDI-DI
04026575432134

Where it was sold

Distributed in Indiana.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Device Defect recalls

Other recent recalls from Waldemar Link GmbH & Co. KG (Mfg Site)

All recalls from Waldemar Link GmbH & Co. KG (Mfg Site)

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Editorial summary by Recall Canary · summary updated 2026-08-12 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification