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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 4
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  1
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
PIONEER
  1
  SUBSTANTIALLY EQUIVALENT 11
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
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device operates differently than expected 77
Break 46
No Known Device Problem 27
No Information 26
Fracture 13
Component missing 13
Mechanical jam 7
Sticking 6
Bent 6
Unintended movement 5
Material integrity issue 4
Failure to Adhere or Bond 4
Loose or intermittent connection 4
Corrosion 3
Material frayed 3
Dislodged or dislocated 3
Implant, removal of 3
Explanted 3
Material deformation 2
Difficult to open or close 2
Material fragmentation 2
Couple, failure to 2
Disassembly 2
Dislocated 1
Device expiration issue 1
Cable break 1
Loose 1
Mechanical issue 1
Difficult to position 1
User used incorrect product for intended use 1
Difficult to remove 1
Replace 1
Material separation 1
Difficult to insert 1
Seal, defective 1
Incomplete or missing packaging 1
Tear, rip or hole in device packaging 1
Defective item 1
Implant breakage or physical damage 1
Detachment of device or device component 1
Positioning Issue 1
Device Difficult to maintain 1
No code available 1
Total Device Problems 283

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 1 0 1 0 0 1 1 4 0
Class III 0 1 0 0 0 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 EXP Pharmaceutical Services Corp II Jul-24-2015
4 PIONEER SURGICAL TECHNOLOGY, INC. II Jul-17-2014
5 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Jul-09-2015
6 Smith & Nephew Inc II Aug-10-2010
7 Synthes (USA) Products LLC II Nov-14-2015
8 Synthes (USA) Products LLC II Aug-27-2015
9 Synthes USA HQ, Inc. II Oct-30-2013

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