Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02) Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) Due to There is a risk that blind screws of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Waldemar Link GmbH & Co. KG (Mfg Site) directly.
Affected Products
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
Quantity: 3785
Why Was This Recalled?
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Where Was This Sold?
This product was distributed to 15 states: AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA
About Waldemar Link GmbH & Co. KG (Mfg Site)
Waldemar Link GmbH & Co. KG (Mfg Site) has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report