NOVATION Femoral Stem — Class II medical device recall Z-2086-2014
Terminated recall by Exactech, Inc., reported 2014-07-30. The femoral stem is lacking specified plasma coating.
| Recall number | Z-2086-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2014-03-07 |
| Classified | 2014-07-21 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2014-08-04 |
| Countries outside the US | ES, GR, JP |
| Quantity | 10 |
| Serial numbers | 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, 2910252 |
| Model numbers | 160-01-13 |
Product
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Reason for recall
The femoral stem is lacking specified plasma 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-2086-2014. 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.