Lower riskMedical device recall · FDA · Published July 6, 2026
Waldemar Link Endo-Model Tibial Plateau Recall: Incorrect Plateau May Cause Surgery
Waldemar Link recalls Endo-Model replacement sets with incorrect Pure Hinge plateau that may require surgery changes and increase implant wear risk. Affected items have specific item numbers and lot codes.
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.
“Waldemar Link Endo-Model Tibial Plateau Recall: Incorrect Plateau May Cause Surgery.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/459417-waldemar-link-endo-model-tibial-plateau-recall-incorrect-plateau-may. Based on FDA recall #Z-2934-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2934-2026%22&limit=1).
The FDA announced on July 6, 2026, that Waldemar Link is recalling Endo-Model Replacement Sets for Rotating Hinge tibial plateaus due to the inclusion of incorrect components. The hazard involves a prolonged or modified surgery if the wrong plateau is implanted.
How to tell if you have it
Brand: Waldemar Link
Product: Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Lot for Implant REF 15-0027/16: 2604069
The hazard
The affected Endo-Model replacement set incorrectly contains a Pure Hinge plateau. This error could lead to a prolonged or modified surgery because the plateau cannot be inserted, requiring an alternative product. If implanted, it is associated with increased risk of wear and reduced standing time of the implant.
Context
GovInfoNow's records show Waldemar Link has issued 21 other recalls since December 4, 2018. Recent similar recalls include the Embrace Drill Tower Recall on February 11, 2026, and the Waldemar Link Endo-Model Plateau Recall on January 12, 2026. Other recent recalls of similar products include Howmedica DURACON XL Angled Tibial Implants (July 30, 2026) and Howmedica TRIATHLON Hinge Insert (July 30, 2026).
How to tell if you have this one
Check for item number 15-0027/16 on the packaging or label. The lot code for implants is 2604069. These products were sold with specific UDI-DI codes starting with 04026575432134.
Brand
Waldemar Link
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for item number 15-0027/16 and lot code 2604069 on the packaging or label.
Where it went and when
Where it was distributed
Distributed in Indiana, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2934-2026 (July 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2934-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.