Novation Element Press-Fit — Class II medical device recall Z-0201-2016
Terminated recall by Exactech, Inc., reported 2015-11-11, distributed in AZ, CO, FL, MD. Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
| Recall number | Z-0201-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2015-09-23 |
| Classified | 2015-11-02 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2017-03-01 |
| Distributed | AZ, CO, FL, MD |
| Quantity | 8 |
| Serial numbers | 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, 4076822 |
| Model numbers | 164-13-09 |
Product
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Reason for recall
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0201-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.