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Class IIOngoing

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model

Recall date · record updated Aug 19, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Waldemar Link GmbH & Co. KG (Mfg Site)
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
Where
Indiana
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99405…

Products

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

    Codes/lots: UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069Quantity: 1 US; 9 OUSRecall no. Z-2934-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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