Recall Z-1901-2016 ยท MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Exactech, Inc.
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.
| Date | Apr 12, 2016 |
| Status | Terminated |
| Reason | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| Root cause | Packaging process control |
| Action | 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 b |
| Quantity | 2 devices. |
| Distribution | Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.