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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical, metal
Regulation Description Surgical mesh.
Product CodeEZX
Regulation Number 878.3300
Device Class 2

Device Problems
Adverse Event Without Identified Device or Use Problem 14
Migration 11
No Apparent Adverse Event 8
Migration or Expulsion of Device 5
Break 4
Packaging Problem 2
Torn Material 2
Incorrect Device Or Component Shipped 2
Appropriate Term/Code Not Available 1
Leak / Splash 1
Stretched 1
Unintended Movement 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Total Device Problems 53

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Oct-30-2015

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