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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device retractor
Regulation Description Manual surgical instrument for general use.
Product CodeGAD
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ADEPT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
APPLE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
EZSURGICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDIN CORP.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCHOLTEN SURGICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
T. KOROS SURGICAL
  SUBSTANTIALLY EQUIVALENT 8
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 37
Fracture 13
Material fragmentation 6
Detachment of device component 4
Tears, rips, holes in device, device material 4
Other (for use when an appropriate device code cannot be identified) 4
Overheating of device or device component 3
Material separation 3
Connection issue 3
Device operates differently than expected 3
Dislodged or dislocated 3
Unintended movement 2
No code available 2
Device-device incompatibility 2
Detachment of device or device component 2
Material integrity issue 2
Replace 2
Malfunction 2
Device maintenance issue 2
Crack 2
Degraded 1
Difficult to deploy 1
Disassembly 1
Flaked 1
Component(s), broken 1
Air leak 1
Failure to Adhere or Bond 1
Bent 1
Migration of device or device component 1
Unintended system motion 1
Corrosion 1
Difficult to insert 1
Leak 1
Failure to align 1
Defective item 1
Device or device fragments location unknown 1
Malposition of device 1
Component or accessory incompatibility 1
Unknown (for use when the device problem is not known) 1
Component missing 1
Device Issue 1
Retraction problem 1
Material rupture 1
Slippage of device or device component 1
Peeled 1
Product quality issue 1
Difficult to remove 1
Mechanical jam 1
No Known Device Problem 1
Scratched material 1
Torn material 1
Difficult to open or close 1
Device handling issue 1
No Information 1
Gas leak 1
Manufacturing or shipping issue associated with device 1
Total Device Problems 137

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 2 0 0 1 4 2 3 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap, Inc. II Dec-31-2015
2 Aesculap, Inc. II Oct-21-2013
3 Alphatec Spine, Inc. II Dec-11-2009
4 Applied Medical Technology Inc II May-05-2016
5 Biomet, Inc. II Mar-10-2016
6 Pemco Inc II Jul-22-2013
7 Sterilmed Inc II Jan-13-2009
8 Stryker Spine II Aug-07-2012
9 Synthes (USA) Products LLC II Aug-19-2015
10 Synthes USA HQ, Inc. II Nov-29-2013
11 Synthes USA HQ, Inc. II Nov-18-2013
12 Synthes, Inc. II Jan-14-2015
13 Synthes, Inc. II Oct-20-2014
14 Synthes, Inc. II Apr-15-2014

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