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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mallet, surgical, general & plastic surgery
Product CodeGFJ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 3 3
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Material Twisted/Bent 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Consequences Or Impact To Patient 2 2
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc. II Dec-17-2019
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