Exactech Recalls Equinoxe Platform Fracture Stem Due to Incorrect Laser Marking
Exactech is recalling 25 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems instead of left stems.
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: This is a Class II recall involving a labeling error (incorrect side marking) without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Exactech, Inc. is recalling 25 units of the Equinoxe Platform Fracture Stem, 6.5mm, Left. The recall is due to a labeling error where the devices may be incorrectly laser marked as right stems when they should be marked as left stems. The product is indicated for cemented use only.
The affected devices were distributed worldwide, including in the United States (CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico) and in Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, the UK, Luxembourg, and Brazil. The specific catalog number is 304-21-07, and the serial ranges are 4968615-4968627 and 4952421-4952432.
Healthcare providers and patients should verify the laser marking on the device to ensure it matches the intended side of use. If a device is found to be incorrectly marked, it should be removed from use and reported to the manufacturer or the FDA.
The recalled product
- Product
- Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 25
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 (3)
- Catalog: 304-21-07
- Serial Ranges: 4968615-4968627
- 4952421-4952432
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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