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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device burr, orthopedic
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTT
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 17
Break 16
Overheating of device or device component 3
Device, or device fragments remain in patient 3
Tip breakage 3
Metal shedding debris 2
Normal 2
Bent 1
Malfunction 1
Device operates differently than expected 1
Other (for use when an appropriate device code cannot be identified) 1
Detachment of device component 1
Flaked 1
Foreign material 1
Fracture 1
Total Device Problems 54

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 0 0 1 0 2 0 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Linvatec Corp. dba ConMed Linvatec II Sep-08-2009
2 The Anspach Effort, Inc. II May-09-2014
3 The Anspach Effort, Inc. II Feb-04-2013
4 The Anspach Effort, Inc. II Oct-21-2011
5 The Anspach Effort, Inc. II Apr-20-2011

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