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
Reported: December 27, 2023 Initiated: November 21, 2023 #Z-0580-2024
Product Description
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
Reason for Recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- N/A
- Distribution
- US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Exactech, Inc.. Units affected: N/A.
Why was this product recalled? ▼
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 27, 2023. Severity: Moderate. Recall number: Z-0580-2024.
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