FDA Device recall Z-1030-2017
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15
- FDA Device
- Class II
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15 by Exactech, citing products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1030-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-07 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, VA |
Product
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Reason
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Identifiers
| code_info | Serial No. 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471…Serial No. 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, 4565752-4565760; Catalog No. 160-70-15; UDI: 10885862033086 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1030-2017%22
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