Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Comprehensive Reverse Shoulder System Recalled by Biomet, Inc. Due to Specific lots of multiple sterile medical devices may...
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 Biomet, Inc. directly.
Affected Products
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
Quantity: 7428
Why Was This Recalled?
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Biomet, Inc.
Biomet, Inc. has 250 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report