Novation Press-Fit Splined RDD — Class II medical device recall Z-2128-2016
Terminated recall by Exactech, Inc., reported 2016-07-13, distributed nationwide. Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as an
| Recall number | Z-2128-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2016-05-26 |
| Classified | 2016-07-05 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2019-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 14 |
| Reason classes | labeling |
| Serial numbers | 4300062, 4300063, 4325742, 4325743, 4325744, 4325745, 4325746, 4325747, 4325748, 4325749, 4325750, 4325751, 4325752, 4325753 |
| Model numbers | 160-33-18 |
| Expiration dates | 2021-02-27, 2021-03-17 |
Product
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.
Reason for recall
Labeled with the incorrect Global Trade Item Number (GTIN). 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-2128-2016. 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.