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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
ANTHOGYR
  SUBSTANTIALLY EQUIVALENT 2
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
CASE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CASE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
COCHLEAR
  SUBSTANTIALLY EQUIVALENT 1
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY MITEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT MICRODENT SYSTEM S.L.U.
  SUBSTANTIALLY EQUIVALENT 1
INFINITUM ETA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE STERILIZATION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.
  SUBSTANTIALLY EQUIVALENT 2
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.
  SUBSTANTIALLY EQUIVALENT 3
K1 MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
MASTEL SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE SERVICES AG
  SUBSTANTIALLY EQUIVALENT 2
O&M HALYARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
PARAGON IMPLANT MFG., 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 3
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 1
SYNTHES GMBH
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM ESPAÑA, SL
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
Z-SYSTEMS AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 26 26
2022 8 8
2023 30 30
2024 18 18
2025 50 50
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 72 72
Device Contamination with Chemical or Other Material 6 6
Problem with Sterilization 5 5
Product Quality Problem 5 5
Failure to Align 4 4
Residue After Decontamination 4 4
Unexpected Color 4 4
Material Split, Cut or Torn 4 4
Device Markings/Labelling Problem 4 4
Material Deformation 4 4
Mechanical Problem 4 4
Extra Components 3 3
Material Discolored 3 3
Material Integrity Problem 3 3
Material Erosion 2 2
Fracture 2 2
Labelling, Instructions for Use or Training Problem 2 2
Corroded 2 2
Illegible Information 2 2
Material Fragmentation 1 1
No Apparent Adverse Event 1 1
Loose or Intermittent Connection 1 1
Osseointegration Problem 1 1
Device-Device Incompatibility 1 1
Structural Problem 1 1
Break 1 1
Device Fell 1 1
Peeled/Delaminated 1 1
Use of Device Problem 1 1
Positioning Problem 1 1
Device Ingredient or Reagent Problem 1 1
Unintended Movement 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 135 135
Failure of Implant 6 6
Insufficient Information 5 5
Unspecified Tissue Injury 2 2
Hemorrhage/Blood Loss/Bleeding 1 1
Inflammation 1 1
Pain 1 1
Swelling/ Edema 1 1
Ambulation or Postural Difficulties 1 1
Discomfort 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 Implant Direct Sybron Manufacturing LLC II Jul-25-2025
4 Jewel Precision Sheet Metal & Machining Co, Inc. II Jun-26-2025
5 Jewel Precision Sheet Metal & Machining Co, Inc. II Jun-25-2025
6 Karl Storz Endoscopy II Jun-21-2023
7 Karl Storz Endoscopy II Jun-21-2023
8 Karl Storz Endoscopy II Dec-29-2021
9 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
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