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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device washer, bolt nut
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeHTN
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
AKROS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
CONMED
  SUBSTANTIALLY EQUIVALENT 2
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
DALLEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MORTISE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 62
Break 7
Migration or Expulsion of Device 7
Difficult To Position 5
Appropriate Term/Code Not Available 5
Insufficient Information 4
Expulsion 3
Fracture 3
Component Missing 2
Failure to Align 2
Device Operates Differently Than Expected 2
Unintended Movement 2
Knotted 1
Failure to Advance 1
Difficult to Advance 1
Fitting Problem 1
Material Fragmentation 1
Misassembly by Users 1
Separation Failure 1
Difficult to Remove 1
Migration 1
Delivery System Failure 1
No Apparent Adverse Event 1
Total Device Problems 115

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. III Sep-30-2016
2 Zimmer Biomet, Inc. II Nov-07-2019

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