FDA-Device2020-06-24Class II
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Biomet
Hazard
Device and tray that houses the device did not pass steam sterilization process validation testing
Sold states
Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND
Affected count
136 units
Manufactured in
6303 Blue Lagoon Dr Ste 100, Miami, FL, United States
Products
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2362-2020Don't want to check this manually?
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