Exactech Equinoxe Humeral Stem Recalled for Incorrect Label Translation
Exactech is recalling Equinoxe humeral stems because outer labels incorrectly described the standard-length implants as 'long' in non-English translations.
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, but the hazard is limited to a labeling error regarding product dimensions without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling specific units of the Equinoxe Platform Fracture, Humeral Stem, Cemented, Right, 10.5mm (REF 304-22-11). The recall was initiated after a distributor in the Netherlands identified that the outer labels contained incorrect translations in languages other than English. Specifically, the labels included the word "long" to describe the implants, even though the recalled products are standard length fracture stems.
The affected products are indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi-arthroplasty is the preferred treatment method. The recall covers all lot numbers in the out-of-state distribution. The products 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.
Healthcare providers and patients should verify the specific reference number and length of the implanted device against the recall notice. If the device matches the recalled description, providers should contact Exactech for further instructions regarding the recall and potential replacement.
The recalled product
- Product
- Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - 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
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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