Exactech Recalls One Novation Femoral Stem Device for Premature Packaging
Exactech is recalling one Novation femoral stem device because it was packaged before the required site-change approval was granted.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text indicates a procedural error (premature packaging) without any reported injuries, illnesses, or specific safety hazards associated with the device itself. This aligns with the rubric for moderate severity involving voluntary precautionary or procedural recalls where risk is theoretical or administrative.
Plain-English summary
Exactech, Inc. is recalling one Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem (Catalog Number 160-10-16). The 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. This procedural error means the device was processed before the necessary regulatory clearance for the site change was finalized.
The single affected device was distributed in Florida, New Jersey, New York, Ohio, Oklahoma, Rhode Island, Tennessee, Virginia, and Hawaii. The device has Product Codes LPH, MEH, LWJ, and JDI, Serial Number 4256338, and an expiration date of January 27, 2021. Users should contact Exactech, Inc. for further instructions regarding the return or replacement of the device.
The recalled product
- Product
- Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; 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 160-10-16
- Serial Number: 4256338
- Exp. 1/27/2021.
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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