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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cerclage, fixation
Regulation Description Bone fixation cerclage.
Product CodeJDQ
Regulation Number 888.3010
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
PIONEER
  SUBSTANTIALLY EQUIVALENT 10
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Break 7
Fracture 6
No Information 5
Component missing 4
Implant, removal of 3
Explanted 3
Couple, failure to 2
Disassembly 1
Dislocated 1
Device expiration issue 1
Material frayed 1
Difficult to insert 1
Loose 1
Difficult to remove 1
Replace 1
Seal, defective 1
Cable break 1
Tear, rip or hole in device packaging 1
Implant breakage or physical damage 1
Total Device Problems 42

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

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Aug-22-2008
2 Biomet, Inc. III Nov-09-2008
3 Smith & Nephew Inc II Aug-10-2010

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