Recall Z-0201-2016 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Exactech, Inc.
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
| Date | Nov 2, 2015 (initiated Sep 23, 2015) |
| Status | Terminated |
| Reason | Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating. |
| Root cause | Under Investigation by firm |
| Action | The firm, Exactech, issued an "IMPORTANT NOTIFICATION-PRODUCT RECALL ADVISORY NOTICE" dated September 23, 2015, by phone and by mail to their consignees. The notice described the product, problem and actions taken. The consignees were instructed to 1) Immediately cease distribution or use of these products. 2) Extend this information to your accounts that may have this product in their possession. 3) Identify and quarantine any of the subject Novation Element Pres Fit Femoral stem in your inventory. 4) Complete and Return the attached Recall Inventory Response Form to Exactech,per the instruct |
| Quantity | 8 |
| Distribution | US Distribution to states of: AZ, CO, FL, and MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080980 | EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS Exactech, Inc., May 6, 2008 |