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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device knife, orthopedic
Product CodeHTS
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2016 2 2
2018 1 1
2019 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5 5
Fracture 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beaver Visitec International, Inc. II Nov-08-2022
2 Becton Dickinson and Company II May-21-2010
3 Stryker Howmedica Osteonics Corp. II Dec-15-2009
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