PlainRecalls
FDA Devices Moderate Class II Terminated

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 s

Reported: July 13, 2016 Initiated: May 26, 2016 #Z-2127-2016

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.

Details

Recalling Firm
Exactech, Inc.
Units Affected
8 units
Distribution
Nationwide Distribuiton to OK, ME, NY, & Hawaii.
Location
Gainesville, FL

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Exactech, Inc.. Units affected: 8 units.
Why was this product recalled? ▼
Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2016. Severity: Moderate. Recall number: Z-2127-2016.

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