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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cement obturator
Regulation Description Surgical mesh.
Product CodeLZN
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  1
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Patient-device incompatibility 36
Failure to osseointegrate 2
Fracture 2
Difficult to position 1
Device remains implanted 1
Tears, rips, holes in device, device material 1
Other (for use when an appropriate device code cannot be identified) 1
No Known Device Problem 1
No code available 1
Air leak 1
Total Device Problems 47

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