Novation Press-Fit Splined — Class II medical device recall Z-1905-2016
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-1905-2016 |
|---|---|
| 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 | 9 devices |
| Serial numbers | 4273184, 4273185, 4273186, 4273187, 4273188, 4273189, 4273190, 4273191, 4273192 |
| Model numbers | 160-30-11 |
| Expiration dates | 2021-02-08 |
Product
Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; 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-1905-2016. 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.