Novation Press-Fit Tapered — Class II medical device recall Z-1902-2016
Terminated recall by Exactech, Inc., reported 2016-06-08, distributed in FL, HI, NJ, NY, OH, OK, RI, TN…. Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approv
| Recall number | Z-1902-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2016-04-12 |
| Classified | 2016-06-02 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2019-07-24 |
| Distributed | FL, HI, NJ, NY, OH, OK, RI, TN, VA |
| Quantity | 4 devices |
| Serial numbers | 4333544, 4333545, 4333546, 4335281 |
| Model numbers | 160-00-13 |
| Expiration dates | 2021-03-22, 2021-03-23 |
Product
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
Reason for recall
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
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-1902-2016. 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.