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.

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Customers were notified 4/12/2016 with a Product Recall Advisory Notice of affected products.In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in your inventory " Complete and Return the attached Recall Inventory Response Form to Exactech, per the instructions provided on the notice itself. According to policy, please contact your Exactech inventory representative within 5 business days to confirm quantities at your location. If you have any inventory restocking questions related to this issue, please contact Kaya Davis at [email protected] or 1-800-392-2832. Please return the products to the following address: Exactech Distribution Center 2411 NW 66th Court Gainesville, Florida 32653 Attention: Kaya Davis [email protected] 352-337-3915 (Fax)