Exactech Equinoxe Shoulder System recalled for loss of vacuum

Plain-English summary

Exactech, Inc. is recalling certain models of its Equinoxe Shoulder System implants due to a defect involving loss of vacuum in the inner-most vacuum bag. The company has received three complaints regarding four affected devices.

Affected units are identified by specific catalog numbers, GTINs, and serial numbers listed in the FDA recall notice. These shoulder system components were distributed in the United States and internationally to countries including Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, and the United Kingdom.

Patients who have received an implant with one of the affected serial numbers should contact their surgeon or healthcare provider to determine if they have a recalled device. Exactech and the FDA are working to address the vacuum loss issue and provide further guidance to healthcare providers.

The recalled product

Product

Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35

Manufacturer

Exactech, Inc.

Category

Medical Device — Orthopedic Implant

Hazard

• loss-of-vacuum
• device-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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