Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0414-2018·Announced 2018-02-07

Exactech Recalls 30 Mislabeled Equinoxe Shoulder Implant Components

Exactech is recalling 30 Equinoxe Cage, Glenoid, Alpha, Small components due to potential mislabeling. 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, Small medical device. The recall was initiated because the products are potentially mislabeled. These components are part of the Equinoxe Shoulder System, which is 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 affected devices have catalog number 314-13-03 and serial numbers ranging from 5013050 to 5013079. The recall covers worldwide distribution to facilities located 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 specific components implanted should contact their healthcare provider to verify the serial numbers of their implants. If the serial numbers match the recalled range, the provider can advise on the appropriate next steps.

The recalled product

Product: Equinoxe Cage, Glenoid, Alpha, Small 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.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
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: 5013050 - 5013079

Distribution

Distributed in 15 states:

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.

See all 2 products in this recall →

Same manufacturer · Exactech, Inc.

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Same hazard · mis labeling