Endo-Model Tibial Plateau Replacement Set Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Waldemar Link GmbH & Co. KG is recalling one Endo-Model Replacement Set in the US due to an incorrect plateau component that may require modified surgery or increase implant wear risk.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 26, 2026 and geographically references Indiana. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
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.
Which Products Are Affected
- Product: Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge
- Item Number: 15-0027/16
- UDI-DI: 04026575432134
- Lot: 2604069
- Quantity: 1 unit distributed in the US (9 units OUS)
- Distribution: Domestic US distribution to Indiana
- Recall Number: Z-2934-2026
What You Should Do
Consumers and healthcare providers should verify inventory against the affected lot and contact the recalling firm for further instructions regarding the incorrect component.
Why This Matters
The mislabeled component poses a risk of surgical delays or reduced implant longevity if used.
Source
FDA recall Z-2934-2026, Waldemar Link GmbH & Co. KG
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,151 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.