Exactech Recalls Equinoxe Platform Fracture Stem Due to Incorrect Laser Marking
Exactech is recalling 12 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems when they are 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: The recall is classified as FDA Class II, and the hazard is a labeling error (incorrect side marking) which fits the rubric for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Exactech, Inc. is recalling 12 units of the Equinoxe Platform Fracture Stem, 6.5mm, Right. The recall is due to a labeling error where the devices may be incorrectly laser marked as right stems when they should have been marked as left stems.
The affected devices are indicated for cemented use only. The recall covers 12 devices with catalog number 304-22-07 and serial numbers ranging from 4971292 to 4971303.
Distribution was worldwide, including the United States (specifically CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico) and international locations in Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, the UK, Luxembourg, and Brazil. Healthcare providers should verify the laser markings on their inventory to ensure the correct side is identified prior to use.
The recalled product
- Product
- Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 12
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 (2)
- Catalog: 304-22-07
- Serial Range: 4971292-4971303
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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