Novation Cemented Plus Femoral Stem — Class II medical device recall Z-1030-2017
Terminated recall by Exactech, Inc., reported 2017-01-25, distributed in AZ, CA, CO, FL, IL, KS, MD, NJ…. Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices a
| Recall number | Z-1030-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2016-11-07 |
| Classified | 2017-01-17 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2019-08-05 |
| Distributed | AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, VA |
| Countries outside the US | CH, DE, ES, IT, JP |
| Quantity | 79 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10885862033086 |
| Serial numbers | 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, 4565752-4565760 |
| Model numbers | 160-70-15 |
Product
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Reason for recall
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
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-1030-2017. 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.