Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Novation Ceramic AHS Cluster-Hole Shell Recalled by Exactech, Inc. Due to Devices were inadvertently sent to packaging and finished...
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 Exactech, Inc. directly.
Affected Products
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
Quantity: 2 devices.
Why Was This Recalled?
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Where Was This Sold?
This product was distributed to 9 states: FL, HI, NJ, NY, OH, OK, RI, TN, VA
About Exactech, Inc.
Exactech, Inc. has 211 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report