Reported Dec 23, 2020 · Terminated
Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
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?
- Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item
- number SP-STA-1021-12 - Product UsageFixation of Cranial bone
- Lot codes and dates
- Lot 078390
- 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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