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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rod, fixation, intramedullary and accessories
Regulation Description Intramedullary fixation rod.
Product CodeHSB
Regulation Number 888.3020
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 3
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DGIMED ORTHO, INC
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
ELLIPSE TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
ELLIPSE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
EMERGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EPIX ORTHOPAEDIC, CORP.
  SUBSTANTIALLY EQUIVALENT 1
FLOW-FX, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES
  SUBSTANTIALLY EQUIVALENT 2
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAFUSE LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
NEOORTHO PRODUTOS ORTOPEDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 4
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 4
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
PEGA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
RENOVO LIFE LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGN FRACTURE CARE INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SONOMA ORTHOPEDIC PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
  SUBSTANTIALLY EQUIVALENT 4
THE ORTHOPEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
WITTENSTEIN INTENS GMBH
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Adverse Event Without Identified Device or Use Problem 1780
Break 1502
Device-Device Incompatibility 405
Fracture 382
Migration or Expulsion of Device 317
Device Operates Differently Than Expected 304
Packaging Problem 266
Device Contaminated during manufacture or shipping 259
Failure to Align 221
Unintended Movement 199
Delivered as Unsterile Product 198
Migration 172
Insufficient Information 165
Fitting Problem 135
Mechanical Jam 117
Appropriate Term/Code Not Available 81
Device Handling Problem 60
Mechanical Problem 60
Difficult to Insert 57
Material Discolored 55
Device Packaging Compromised 52
Difficult to Remove 51
Material Twisted / Bent 40
Screw 36
Material Deformation 34
Sticking 31
Unsealed Device Packaging 31
No Apparent Adverse Event 31
Use of Device Problem 30
Material Fragmentation 30
Bent 29
Failure To Adhere Or Bond 29
Malposition of device 25
Contamination / decontamination Problem 24
Nonstandard device 23
Detachment of Device or device Component 20
Tear, Rip or Hole in Device Packaging 20
Difficult to Advance 19
Defective Device 18
Failure to Advance 18
Crack 17
Connection Problem 16
Disassembly 15
Difficult To Position 15
Detachment Of Device Component 15
Improper or Incorrect Procedure or Method 14
Device Markings / Labelling Problem 13
Positioning Problem 13
Material Integrity Problem 12
Component Missing 12
Device Difficult to Maintain 12
Activation Failure Including Expansion Failures 11
Device Dislodged or Dislocated 10
Inflation Problem 10
Loose or Intermittent Connection 10
Device Contamination with Chemical or Other Material 10
Out-Of-Box Failure 10
Incomplete or Missing Packaging 9
Device Damaged by Another Device 9
Tip 9
Defective Component 8
Corroded 7
Positioning Failure 7
Inadequacy of Device Shape and/or Size 7
Device Slipped 7
Noise, Audible 7
Entrapment of Device 6
Off-Label Use 6
Patient Device Interaction Problem 6
Device Operational Issue 6
Compatibility Problem 5
Loss of or Failure to Bond 5
Misassembled 5
Failure to Disconnect 5
Manufacturing, Packaging or Shipping Problem 4
Device Damaged Prior to Use 4
Device Disinfection Or Sterilization Issue 4
Naturally Worn 4
Device Expiration Issue 4
Separation Failure 4
Activation, Positioning or Separation Problem 4
Unstable 4
Patient-Device Incompatibility 4
Device Fell 3
Metal Shedding Debris 3
Material Separation 3
Misassembly by Users 3
Collapse 3
Torn Material 3
Thread 3
Dull, Blunt 3
Material Distortion 3
Mechanics Altered 3
Biocompatibility 2
Material Erosion 2
Flaked 2
Rod 2
Disconnection 2
Knife 2
Shelf Life Exceeded 2
Total Device Problems 7735

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 CarboFix Orthopedics, Ltd. II Jun-14-2016
3 Integra LifeSciences Corp. II Mar-23-2017
4 Medacta Usa II Nov-12-2014
5 Ortho Solutions Inc II Jul-28-2017
6 OrthoPediatrics Corp II Oct-13-2019
7 OrthoPediatrics Corp III Dec-22-2016
8 Pega Medical Inc. II Aug-14-2019
9 Pega Medical Inc. II Apr-29-2015
10 Pega Medical Inc. II Apr-02-2015
11 Pega Medical Inc. II Apr-18-2014
12 Pega Medical Inc. II Apr-10-2014
13 Stryker GmbH II Aug-22-2018
14 Stryker GmbH II Jul-10-2018
15 Stryker Howmedica Osteonics Corp. II Sep-13-2016
16 Stryker Howmedica Osteonics Corp. II Feb-25-2016
17 Stryker Howmedica Osteonics Corp. II Oct-14-2014
18 Stryker Howmedica Osteonics Corp. II Jan-28-2014
19 Synthes (USA) Products LLC II Feb-13-2018
20 Synthes (USA) Products LLC II Nov-19-2016
21 Synthes (USA) Products LLC II Dec-04-2015
22 Synthes (USA) Products LLC II Oct-15-2015
23 Synthes (USA) Products LLC II Jul-16-2015
24 Synthes, Inc. II Jun-26-2015
25 Synthes, Inc. II May-12-2015
26 Synthes, Inc. II Mar-30-2015
27 Synthes, Inc. II Nov-14-2014
28 Tornier, Inc II Jul-29-2015
29 Vilex In Tennessee Inc II Jun-08-2015
30 Wright Medical Technology, Inc. II Apr-13-2018
31 Zimmer Biomet, Inc. II Nov-14-2018
32 Zimmer Biomet, Inc. II Oct-18-2018
33 Zimmer Biomet, Inc. II Sep-25-2018
34 Zimmer Biomet, Inc. II Sep-13-2018
35 Zimmer Biomet, Inc. II Apr-25-2018
36 Zimmer Biomet, Inc. II Apr-20-2018
37 Zimmer Biomet, Inc. II Mar-27-2018
38 Zimmer Biomet, Inc. II Mar-14-2018
39 Zimmer Biomet, Inc. II Mar-14-2018
40 Zimmer Biomet, Inc. II Jan-29-2018
41 Zimmer Biomet, Inc. II Jun-15-2017
42 Zimmer Biomet, Inc. II Jun-01-2017
43 Zimmer Biomet, Inc. II Mar-20-2017
44 Zimmer Gmbh II Oct-14-2015
45 Zimmer Manufacturing B.V. II May-16-2016
46 Zimmer Manufacturing B.V. II Mar-12-2016
47 Zimmer, Inc. II Jul-13-2015
48 Zimmer, Inc. II Feb-20-2014

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