Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tibila Insert CK Recalled by Ortho Development Corporation Due to Ortho Development is recalling various Pivot Bipolar Cup,...
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 Ortho Development Corporation directly.
Affected Products
Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
Quantity: 1
Why Was This Recalled?
Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho Development Corporation
Ortho Development Corporation has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report