FDA-Device2020-12-23Class II
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 de
Biomet, Inc.
Hazard
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.
Sold states
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Affected count
7428
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0619-2021Don't want to check this manually?
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