Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38 Recalled by Exactech, Inc. Due to Instructions for use (IFU) is updated to clarify...
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
EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
Quantity: 813
Why Was This Recalled?
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
Where Was This Sold?
This product was distributed to 31 states: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, ME, MD, MA, MN, NV, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI
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