Recall Z-0538-2018 · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Exactech, Inc.
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic repla
| Date | Jan 18, 2018 (initiated Oct 9, 2017) |
| Status | Terminated |
| Reason | Wrong device description of the label identifying the implant |
| Root cause | Error in labeling |
| Action | Exactech sent an Urgent Medical Device Recall letter dated October 9, 2017, informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions, please call (800) 392-2832. |
| Quantity | 34 |
| Distribution | US Distribution to the states of : AL, CA, CO, FL, MD. and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162732 | Exactech® Alteon® HA Femoral Stem Exactech, Inc., Apr 26, 2017 |