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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
Regulation Description Sterilization wrap.
Product CodeKCT
Regulation Number 880.6850
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANTHOGYR
  SUBSTANTIALLY EQUIVALENT 2
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 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
CASE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CASE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
COCHLEAR
  SUBSTANTIALLY EQUIVALENT 1
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT MICRODENT SYSTEM S.L.U.
  SUBSTANTIALLY EQUIVALENT 1
INFINITUM ETA LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE STERILIZATION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.
  SUBSTANTIALLY EQUIVALENT 3
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.
  SUBSTANTIALLY EQUIVALENT 3
K1 MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ ENDOSCOPY AMERICA INC
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPYAMERICA INC
  SUBSTANTIALLY EQUIVALENT 1
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOBEL BIOCARE SERVICES AG
  SUBSTANTIALLY EQUIVALENT 2
O&M HALYARD, INC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED LLC
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 4
S.I.N. – SISTEMA DE IMPLANTE NACIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
SOADCO, S.L.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN IMPLANTS (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
STERICUBE, LLC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRAUMANN USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
SUMMITT MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
SWEDEN & MARTINA S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES GMBH
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
Z-SYSTEMS AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 66 66
2021 26 26
2022 8 8
2023 30 30
2024 18 18
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 59 59
Material Puncture/Hole 40 40
Contamination /Decontamination Problem 6 6
Device Contamination with Chemical or Other Material 5 5
Material Split, Cut or Torn 4 4
Device Markings/Labelling Problem 4 4
Defective Component 4 4
Failure to Align 4 4
Material Deformation 4 4
Unexpected Color 4 4
Improper Chemical Reaction 4 4
Problem with Sterilization 3 3
Break 2 2
Mechanical Problem 2 2
Peeled/Delaminated 2 2
Material Erosion 2 2
Labelling, Instructions for Use or Training Problem 2 2
Residue After Decontamination 2 2
Illegible Information 2 2
Fracture 2 2
Corroded 2 2
Device Ingredient or Reagent Problem 1 1
Crack 1 1
Device Fell 1 1
Material Fragmentation 1 1
Use of Device Problem 1 1
Material Perforation 1 1
Sharp Edges 1 1
Packaging Problem 1 1
Appropriate Term/Code Not Available 1 1
Inaccurate Information 1 1
Difficult to Open or Close 1 1
Loose or Intermittent Connection 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 96 96
No Known Impact Or Consequence To Patient 32 32
No Patient Involvement 25 25
Failure of Implant 5 5
Insufficient Information 5 5
No Code Available 2 2
Laceration(s) 2 2
Unspecified Tissue Injury 2 2
Inflammation 1 1
Pain 1 1
No Consequences Or Impact To Patient 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Mar-09-2023
2 Carefusion 2200 Inc II Nov-11-2022
3 Intuitive Surgical, Inc. II Jun-09-2020
4 Karl Storz Endoscopy II Jun-21-2023
5 Karl Storz Endoscopy II Jun-21-2023
6 Karl Storz Endoscopy II Dec-29-2021
7 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
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