FDA Device recall Z-0201-2016
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fix…
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fix… by Exactech, citing eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0201-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-23 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Exactech |
| Distribution | AZ, CO, FL, MD |
Product
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Reason
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Identifiers
| code_info | Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0201-2016%22
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