Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EXp Tibial Insert Recalled by Stelkast Co Due to Difficulty locking EXp tibial inserts into tibial trays,...
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 Stelkast Co directly.
Affected Products
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Quantity: 553
Why Was This Recalled?
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
Where Was This Sold?
This product was distributed to 10 states: CA, GA, IL, IN, KS, MD, NY, PA, TX, WA
About Stelkast Co
Stelkast Co has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report