Reported Jun 24, 2020 · Terminated
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Biomet
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 · 6303 Blue Lagoon Dr Ste 100 · Miami, FL · 33126-6023
Is this the product you have?
Biomet Outer Sheath 4.5/5.06.5- Orthopedic
- Manual Surgical Instrument Product Code14235
- Lot codes and dates
- All lots
- Amount recalled
- 136 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Device and tray that houses the device did not pass steam sterilization process validation testing
This product could cause temporary or reversible health problems — stop using it.
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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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