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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sterilization wrap containers, trays, cassettes & other accessories
Product CodeKCT
Regulation Number 880.6850
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 8
AESCULAP, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AMMED SURGICAL EQUIPMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
ANTHOGYR
  SUBSTANTIALLY EQUIVALENT 3
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG
  SUBSTANTIALLY EQUIVALENT 1
AVALIGN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVINENT IMPLANT SYSTEM S.L.U.
  SUBSTANTIALLY EQUIVALENT 1
AVINENT IMPLANT SYSTEM, S.L.U.
  SUBSTANTIALLY EQUIVALENT 1
AYGUN SURGICAL INSTRUMENTS CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BAHADIR USA CORP.
  SUBSTANTIALLY EQUIVALENT 3
BAHADIR USA LLC
  SUBSTANTIALLY EQUIVALENT 1
BEGO IMPLANT SYSTEMS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BIOTECH DENTAL, SAS
  SUBSTANTIALLY EQUIVALENT 1
CALDERA MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200 INC
  SUBSTANTIALLY EQUIVALENT 2
CAREFUSION 2200, INC.
  SUBSTANTIALLY EQUIVALENT 2
CASE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
CASE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
COCHLEAR
  SUBSTANTIALLY EQUIVALENT 1
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONFORMIS, INC
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CONMED LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA INC.
  SUBSTANTIALLY EQUIVALENT 1
ELLIPSE TECHNOLOGIES, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ENTELLUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ERMIS MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 1
FXDEVICES
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 3
HOLOGIC, INC
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT DIRECT SYBRON MANUFACTURING , LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 2
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
JEWEL PRECISION SHEET METAL & MACHINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.
  SUBSTANTIALLY EQUIVALENT 7
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.
  SUBSTANTIALLY EQUIVALENT 2
K1 MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 4
KARL STORZ ENDOSCOPY AMERICA INC
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPYAMERICA INC
  SUBSTANTIALLY EQUIVALENT 1
MACPHERSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK, USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROLINE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MILTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 3
NOBEL BIOCARE SERVICES AG
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
O&M HALYARD, INC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LT
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 3
OSTEOMED LLC
  SUBSTANTIALLY EQUIVALENT 2
OSUNG MND CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OTICON MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
PARAGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PARAGON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PMBS, LLC
  SUBSTANTIALLY EQUIVALENT 2
RESTORE MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROBINSON MEDSURG LLC
  SUBSTANTIALLY EQUIVALENT 1
RP MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
S.I.N. – SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SKLAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC., ENDOSCOPY DIV.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW INC., ENDOSCOPY DIVISION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
SOADCO, S.L.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN IMPLANTS (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
STERICUBE, LLC
  SUBSTANTIALLY EQUIVALENT 1
STERILUCENT, INC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
STERIZIGN PRECISION TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRAUMANN USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
SUMMIT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
SUMMITT MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
SWEDEN & MARTINA S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
SYBRON DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
SYMMETRY SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC / DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
T.A.G. MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
THOMPSON SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
Z-SYSTEMS AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 6 6
2016 16 16
2017 3 3
2018 22 22
2019 15 15
2020 66 66
2021 26 26
2022 8 8
2023 30 30
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 72 72
Material Puncture/Hole 25 25
Crack 14 14
Device Operates Differently Than Expected 11 11
Contamination /Decontamination Problem 7 7
Device Markings/Labelling Problem 5 5
Material Discolored 5 5
Break 4 4
Corroded 4 4
Defective Component 4 4
Failure to Align 4 4
Improper Chemical Reaction 4 4
Material Split, Cut or Torn 4 4
Unexpected Color 4 4
Device Contamination with Chemical or Other Material 3 3
Material Deformation 3 3
Defective Device 3 3
Problem with Sterilization 3 3
Flaked 3 3
Hole In Material 3 3
Labelling, Instructions for Use or Training Problem 2 2
Loose or Intermittent Connection 2 2
Fracture 2 2
Material Fragmentation 2 2
Device Reprocessing Problem 2 2
Contamination 2 2
Use of Device Problem 2 2
Peeled/Delaminated 2 2
Residue After Decontamination 2 2
Smoking 2 2
Material Perforation 2 2
Device Damaged Prior to Use 2 2
Difficult to Open or Close 2 2
Appropriate Term/Code Not Available 2 2
Illegible Information 2 2
Inaccurate Information 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Ingredient or Reagent Problem 1 1
Sharp Edges 1 1
Device Fell 1 1
Moisture or Humidity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Osseointegration Problem 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Torn Material 1 1
Tear, Rip or Hole in Device Packaging 1 1
Split 1 1
Loss of Power 1 1
Material Separation 1 1
Metal Shedding Debris 1 1
Improper or Incorrect Procedure or Method 1 1
Thermal Decomposition of Device 1 1
Material Disintegration 1 1
Material Erosion 1 1
Fire 1 1
Degraded 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 79 79
No Clinical Signs, Symptoms or Conditions 71 71
No Patient Involvement 31 31
No Information 5 5
Failure of Implant 5 5
No Consequences Or Impact To Patient 5 5
Insufficient Information 4 4
No Code Available 2 2
Laceration(s) 2 2
Pain 1 1
Sprain 1 1
Inflammation 1 1
Injury 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Unspecified Tissue Injury 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Feb-22-2011
2 Aesculap Implant Systems LLC II Feb-15-2018
3 Carefusion 2200 Inc II Mar-09-2023
4 Carefusion 2200 Inc II Nov-11-2022
5 Innovative Sterlization Technologies LLC II Oct-22-2015
6 Integra York PA, Inc II Sep-11-2014
7 Intuitive Surgical, Inc. II Jun-09-2020
8 Karl Storz Endoscopy II Jun-21-2023
9 Karl Storz Endoscopy II Jun-21-2023
10 Karl Storz Endoscopy II Dec-29-2021
11 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
12 PMBS, LLC II Mar-25-2016
13 Smith & Nephew, Inc. Endoscopy Division II Jun-24-2011
14 Stryker Endoscopy II Jun-22-2011
15 Symmetry Medical/SSI II Jan-27-2014
16 Symmetry Surgical, Inc. II Jan-11-2017
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