Device product
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage 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.
Z-2127-2016
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 74317
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-2127-2016
Official wording
Reason: Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
Code information: Catalog #: 160-33-17; Serial#: 4192419, 4192420; Exp Date: 11/28/2020. Catalog #: 160-33-17; Serial#: 4223628, 4223629, 4223630, 4223631, 4223632, 4223633; Exp Date: 01/02/2021.
Distribution pattern: Nationwide Distribuiton to OK, ME, NY, & Hawaii.
Derived failure modes
-
Unknown
Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.