Recall Z-1030-2017 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Exactech, Inc.
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
| Date | Nov 7, 2016 |
| Status | Terminated |
| Reason | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. |
| Root cause | Under Investigation by firm |
| Action | In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at kaya@exac.com or 1-800-392-2832. |
| Quantity | 79 units |
| Distribution | AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083392 | NOVATION 12/14 CEMENTED FEMORAL STEMS Exactech, Inc., Dec 17, 2008 |