FDA Device recall Z-2127-2016
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17
- FDA Device
- Class II
- terminated
- Published 2016-07-13
On 2016-07-13 the FDA classified a Class II recall of Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17 by Exactech, citing labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2127-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-26 |
| Published | 2016-07-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | US |
Product
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems 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 proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.
Reason
Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
Identifiers
| code_info | Catalog #: 160-33-17; Serial#: 4192419, 4192420; Exp Date: 11/28/2020. Catalog #: 160-33-17; Serial#: 4223628, 4223629,…Catalog #: 160-33-17; Serial#: 4192419, 4192420; Exp Date: 11/28/2020. Catalog #: 160-33-17; Serial#: 4223628, 4223629, 4223630, 4223631, 4223632, 4223633; Exp Date: 01/02/2021. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2127-2016%22
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