Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Novation Press-Fit Splined RDD Recalled by Exactech, Inc. Due to Labeled with the incorrect Global Trade Item Number...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Exactech, Inc. directly.
Affected Products
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.
Quantity: 14
Why Was This Recalled?
Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Exactech, Inc.
Exactech, Inc. has 211 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report