Exactech Recalls Novation Hip Stems Due to Incorrect GTIN Labeling
Exactech is recalling 14 Novation femoral stems because they were labeled with an incorrect Global Trade Item Number (GTIN). The error identifies the devices as a different product.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a labeling error (incorrect GTIN) which is a documentation issue. The rubric classifies documentation issues and packaging-only problems as Low severity (Score 1).
Plain-English summary
Exactech, Inc. is recalling 14 units of Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. These medical devices are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to conditions such as osteoarthritis, rheumatoid arthritis, and osteonecrosis.
The recall was initiated because the devices were labeled with an incorrect Global Trade Item Number (GTIN). The GTIN on the label incorrectly identifies the devices as another product. The affected units are distributed nationwide to Oklahoma, Maine, New York, and Hawaii.
The recall involves specific catalog and serial numbers with expiration dates in 2021. Consumers and healthcare providers should verify the GTIN on the device labels against the recall notice to determine if their inventory is affected. If the devices match the recalled serial numbers, they should be removed from use and returned to the manufacturer or distributor.
The recalled product
- 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-tr
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- Catalog #: 160-33-18
- Serial#: 4300062
- 4300063
- Exp Date: 02/27/2021. Catalog #: 160-33-18
- Serial#:4325742
- 4325743
- 4325744
- 4325745
- 4325746
- 4325747
- 4325748
- 4325749
- 4325750
- 4325751
- 4325752
- 4325753
- Exp Date: 03/17/2021.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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