Exactech Equinoxe Humeral Stem Recalled for Incorrect Label Translation
Exactech is recalling 2,910 Equinoxe humeral stems because outer labels incorrectly described the standard-length implants as 'long' in non-English translations.
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 hazard is limited to a labeling error (incorrect translation of length) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling 2,910 units of the Equinoxe Platform Fracture, Humeral Stem, Cemented, Right, 6.5mm (REF 304-22-07). The recall was initiated after a distributor in the Netherlands identified that the outer labels contained incorrect translations. Specifically, the non-English versions of the labels included the word "long" to describe the implants, whereas the devices are standard length fracture stems.
The affected devices were distributed internationally to Australia, Austria, Brazil, Canada, China, Colombia, France, Germany, Guatemala, India, Italy, Japan, Luxembourg, the Netherlands, Singapore, South Korea, Spain, Sweden, and the United Kingdom. The recall covers all lot numbers in the out-of-state distribution.
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi-arthroplasty is determined by the surgeon to be the preferred method of treatment. Consumers and healthcare providers should contact Exactech for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 2,910
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 (1)
- All lot numbers in OUS distribution.
Distribution
Distribution scope not specified by the agency.
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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