Z-2127-2016 Class II Terminated
FDA device recall Z-2127-2016 was initiated by Exactech, Inc. on May 26, 2016 and is designated Class II. Reason for recall: Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another. The recall status is terminated (terminated Jul 26, 2019). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 13, 2016
- Initiation Date
- May 26, 2016
- Termination Date
- Jul 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
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.
Reason for Recall
Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
Distribution Pattern
Nationwide Distribuiton to OK, ME, NY, & Hawaii.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2127-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026