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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device single-use reprocessed ultrasonic surgical instruments
Definition Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNLQ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2021 40 40
2022 31 32
2023 16 17
2024 19 19
2025 44 44
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 41 41
Use of Device Problem 25 25
Break 23 23
Detachment of Device or Device Component 14 14
Material Fragmentation 12 12
Material Deformation 9 9
Mechanical Problem 5 5
Melted 4 4
Crack 3 5
Appropriate Term/Code Not Available 3 3
Insufficient Information 2 2
Failure to Seal 2 2
Activation Failure 2 2
Device Remains Activated 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 3
Failure to Fire 1 1
No Audible Prompt/Feedback 1 1
Structural Problem 1 1
Connection Problem 1 1
Difficult to Open or Close 1 1
Compatibility Problem 1 1
Self-Activation or Keying 1 1
Smoking 1 1
Energy Output Problem 1 2
Peeled/Delaminated 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Excessive Heating 1 1
Activation Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Temperature Problem 1 1
Unstable Capture Threshold 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 118 119
Insufficient Information 19 20
Foreign Body In Patient 13 13
Hemorrhage/Bleeding 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bowel Perforation 1 1
Bowel Burn 1 1
Purulent Discharge 1 1
Burn(s) 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-10-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Oct-16-2023
3 Stryker Sustainability Solutions II Nov-12-2025
4 Stryker Sustainability Solutions II Mar-31-2021
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