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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone cement, antibiotic
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Product CodeMBB
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Loss of or failure to bond 56
Infusion or flow issue 46
No Information 12
No flow 11
No code available 10
Loose 7
Implant, removal of 6
Loss of osseointegration 5
Device operates differently than expected 4
Device packaging compromised 2
Malfunction 2
Migration of device or device component 2
No Known Device Problem 2
Sediment, precipitate or deposit in device or device ingredient 1
Temperature issue 1
Manufacturing or shipping issue associated with device 1
Device emits odor 1
Shelf life exceeded 1
Shipping damage or problem 1
Size incorrect for patient 1
Slippage of device or device component 1
Unstable 1
Unknown (for use when the device problem is not known) 1
Device damaged prior to use 1
Tear, rip or hole in device packaging 1
Device expiration issue 1
Fracture 1
Total Device Problems 179

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 0 0 0 0 0 1 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Mar-05-2015
2 DePuy Orthopaedics, Inc. II Oct-23-2013
3 Stryker Howmedica Osteonics Corp. II Jan-10-2007
4 Zimmer, Inc. II Jan-13-2014

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