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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mixer, cement, for clinical use
Regulation Description Cement mixer for clinical use.
Product CodeJDZ
Regulation Number 888.4210
Device Class 1

MDR Year MDR Reports MDR Events
2020 167 200
2021 58 71
2022 46 50
2023 65 330
2024 28 43
2025 20 42
2026 227 229

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 229 229
Device Contaminated During Manufacture or Shipping 145 149
Packaging Problem 74 74
Detachment of Device or Device Component 68 357
Delivered as Unsterile Product 27 40
Material Disintegration 21 71
Insufficient Device Problem Information 6 6
Tear, Rip or Hole in Device Packaging 6 6
Manufacturing, Packaging or Shipping Problem 3 3
Fracture 3 3
Mechanical Jam 2 2
Material Discolored 2 2
Break 2 2
Patient Device Interaction Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Dislodged or Dislocated 1 1
Decrease in Pressure 1 1
Material Twisted/Bent 1 1
Expulsion 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Physical Resistance/Sticking 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 444 795
No Patient Involvement 132 153
No Known Impact Or Consequence To Patient 23 38
Insufficient Information 10 265
No Consequences Or Impact To Patient 7 25
No Information 4 4
Death 1 1
Unspecified Infection 1 1
Stenosis 1 1
Joint Disorder 1 1
Pulmonary Embolism 1 1
Failure of Implant 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Heraeus Medical GmbH (Dental Division) III Apr-29-2026
2 Zimmer, Inc. II Apr-24-2026
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