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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthopedic tray
Regulation Description Manual surgical instrument for general use.
Definition This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOJH
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 38 38
2021 40 40
2022 27 27
2023 44 44
2024 133 133
2025 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Break 44 44
Appropriate Term/Code Not Available 38 38
Material Integrity Problem 32 32
Adverse Event Without Identified Device or Use Problem 17 17
Contamination 16 16
Contamination /Decontamination Problem 15 15
Fracture 11 11
Component Missing 8 8
Material Fragmentation 7 7
Material Puncture/Hole 5 5
Crack 5 5
Fluid/Blood Leak 5 5
Material Split, Cut or Torn 4 4
Detachment of Device or Device Component 4 4
Device Contamination with Chemical or Other Material 4 4
Insufficient Information 4 4
Material Separation 4 4
Use of Device Problem 4 4
Material Twisted/Bent 3 3
Fire 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Frayed 3 3
Device Fell 2 2
Patient Device Interaction Problem 2 2
Leak/Splash 2 2
Packaging Problem 2 2
Output Problem 2 2
Incomplete or Missing Packaging 2 2
Defective Component 2 2
Inadequacy of Device Shape and/or Size 2 2
Improper Chemical Reaction 2 2
Device Markings/Labelling Problem 2 2
Unraveled Material 1 1
Suction Problem 1 1
Problem with Sterilization 1 1
Microbial Contamination of Device 1 1
Material Too Rigid or Stiff 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Device Contaminated During Manufacture or Shipping 1 1
Flaked 1 1
Delivered as Unsterile Product 1 1
Material Discolored 1 1
Moisture Damage 1 1
Degraded 1 1
Overheating of Device 1 1
Scratched Material 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 139 139
Foreign Body In Patient 59 59
Insufficient Information 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Pain 11 11
No Known Impact Or Consequence To Patient 9 9
Needle Stick/Puncture 4 4
Ambulation Difficulties 3 3
Blister 3 3
No Consequences Or Impact To Patient 3 3
Necrosis 3 3
Laceration(s) 3 3
Swelling/ Edema 2 2
Rash 2 2
No Code Available 2 2
Device Embedded In Tissue or Plaque 2 2
Fluid Discharge 2 2
Superficial (First Degree) Burn 2 2
Failure of Implant 2 2
Extravasation 2 2
Burn(s) 2 2
Impaired Healing 2 2
Decreased Sensitivity 1 1
Osteopenia/ Osteoporosis 1 1
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Foreign Body Reaction 1 1
No Information 1 1
Fall 1 1
Exposure to Body Fluids 1 1
Loss of Range of Motion 1 1
Abrasion 1 1
Seizures 1 1
Swelling 1 1
Weakness 1 1
Pulmonary Embolism 1 1
Wound Dehiscence 1 1
Skin Inflammation/ Irritation 1 1
Numbness 1 1
Reaction 1 1
Non-union Bone Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems Inc II Mar-14-2025
3 American Contract Systems Inc II Jul-05-2024
4 American Contract Systems, Inc. II Jun-06-2025
5 American Contract Systems, Inc. II Sep-24-2024
6 American Contract Systems, Inc. II Aug-07-2024
7 American Contract Systems, Inc. II Jan-26-2024
8 American Contract Systems, Inc. III Jun-15-2023
9 American Contract Systems, Inc. II Sep-08-2022
10 American Contract Systems, Inc. II May-06-2022
11 Avid Medical, Inc. II Mar-19-2020
12 Cardinal Health 200, LLC II Feb-10-2025
13 Cardinal Health 200, LLC II Jan-15-2025
14 Cardinal Health 200, LLC II Oct-10-2023
15 MEDLINE INDUSTRIES, LP - Northfield I May-31-2025
16 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
17 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
18 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
19 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
20 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
24 MEDLINE INDUSTRIES, LP - Northfield II Nov-08-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
26 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
27 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
28 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
29 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
30 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
31 MEDLINE INDUSTRIES, LP - Northfield II May-29-2024
32 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
33 MEDLINE INDUSTRIES, LP - Northfield II Aug-10-2023
34 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
35 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
36 MEDLINE INDUSTRIES, LP - Northfield II May-26-2023
37 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
38 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
39 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
40 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
41 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
42 Medline Industries Inc II Aug-09-2021
43 Medline Industries Inc II Feb-11-2020
44 ROi CPS LLC II Apr-25-2023
45 ROi CPS LLC II Nov-23-2022
46 ROi CPS LLC II Feb-28-2022
47 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
48 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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