Exactech Recalls 30 Equinoxe Shoulder Implants Due to Mislabeling
Exactech is recalling 30 Equinoxe shoulder implants because they may be mislabeled. The devices were distributed to facilities in 15 US states, Puerto Rico, and Switzerland.
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 involves a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Exactech, Inc. is recalling 30 units of the Equinoxe Cage, Glenoid, Alpha, Medium shoulder implant. The recall was initiated because the devices are potentially mislabeled. 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.
The affected devices are identified by Catalog # 314-13-03 and Serial Range 5013020 - 5013049. These units were distributed worldwide to facilities in the states of Ohio, Wisconsin, Arizona, Georgia, Virginia, California, Oklahoma, Minnesota, Tennessee, Maine, Colorado, South Carolina, Florida, and Alabama, as well as Puerto Rico and Switzerland.
The FDA has classified this recall as Class II. Patients who have had these implants should contact their healthcare provider for guidance regarding the mislabeling.
The recalled product
- Product
- Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: 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…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 30
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)
- Catalog #: 314-13-03 Serial Range: 5013020 - 5013049
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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