Exactech Recalls One Novation Femoral Stem for Premature Packaging
Exactech is recalling one Novation femoral stem device because it was packaged before the required FDA site-change approval was granted.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a procedural error (packaging before approval) rather than a reported defect or injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling one unit of the Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem (Catalog Number 160-00-14). This device is intended for use in primary total hip arthroplasty.
The recall was initiated because the device was inadvertently sent to packaging and finished goods prior to the approval of the PMA site-change supplement. The agency has classified this recall as Class II.
The single affected device was distributed in Florida, New Jersey, New York, Ohio, Oklahoma, Rhode Island, Tennessee, Virginia, and Hawaii. The device has the following identifiers: Product Codes LPH, MEH, LWJ, JDI; Serial Number 4252802; and an expiration date of 1/25/2021. Healthcare providers and facilities should contact Exactech to return the device.
The recalled product
- Product
- Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.
- Manufacturer
- Exactech, Inc.
- Affected units
- 1
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 (7)
- Product Codes: LPH
- MEH
- LWJ
- JDI
- Catalog Number 160-00-14
- Serial Number: 4252802
- Exp. 1/25/2021.
Distribution
Part of a larger recall action
This product is one of 6 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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