Reported Dec 23, 2020 · Terminated
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553,…
Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
Comprehensive Reverse Shoulder SystemItem numbers 115394115395115396115398180550180551180552180553180554180555180556180557180558180559180560180562 -
- Product Usageindicated 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
- Lot codes and dates
- Lots
95 of 95 codes
208000270240270260208010214760270290270300270310484060484150208130155060208270472020193140193200193220193300272150272290354260354350497880497910497930497970498680498690498700509140214470214490214500214520154290154300154360272530498790498800498860498870154420154430214610272620272680354050354090354110354120354130354150498880498890498910498920498940498960214630
- Lots
- Amount recalled
- 7428
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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