2,726 results
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56ms
·
Sources: EU EUDAMED, US FDA
The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
FDA Enforcement
Class II
·Terminated·BIOMET FRANCE S.A.R.L.·June 17, 2015
OPTIPAC 60 REFOBACIN® BONE CEMENT R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·October 20, 2016
OPTIPAC 60 REFOBACIN® PLUS BONE CEMENT
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·October 20, 2016
OPTIPAC-S 40 REFOBACIN BONE CEMENT R
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·October 3, 2016
BIOMET BONE CEMENT R 40X1
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·October 24, 2016
REFOBACIN BONE CEMENT R 40X2
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·November 16, 2016
OPTIPAC 80 REFOBACIN BONE CEMENT R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·November 11, 2016
OPTIPAC-S 60 REFOBACIN BONE CEMENT R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·October 25, 2016
ENDOBON XENOGRAFT GRANULES 0.5ML
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LYC·December 30, 2016
REFOBACIN REVISION 40G
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·December 30, 2016
REFOBACIN REVISION 1X40
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·October 24, 2016
OPTIPAC-S 80 REFOBACIN BONE CEMENT R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·November 1, 2016
TESS HUMERAL INSERT TH 6 DIA36 S0
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·November 18, 2016
REFOBACIN BONE CEMENT R 40X1
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·December 16, 2016
REFOBACIN REVISION 40X1
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·November 2, 2016
OPTIPAC-S 40 REFOBACIN BONE CEMENT R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·October 25, 2016
ENDOBON XENOGRAFT GRANULES .5ML,500-1000
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LYC·October 14, 2016
REFOBACIN BONE CEMENT R 1X40
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·October 31, 2016
REFOBACIN BONE CEMENT R 2X40G
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·October 11, 2016
REFOBACIN PLUS BONE CEMENT 20
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·November 2, 2016