Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ergo 3.2mm K-wire - Product Usage: The devices is used Recalled by Exactech, Inc. Due to Potential for the wire to fracture at the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Exactech, Inc. directly.
Affected Products
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
Quantity: 158 devices
Why Was This Recalled?
Potential for the wire to fracture at the threads and remain in the glenoid.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Exactech, Inc.
Exactech, Inc. has 211 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report