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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
2021 40 41
2022 27 28
2023 44 45
2024 133 133
2025 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Break 50 50
Appropriate Term/Code Not Available 38 38
Material Integrity Problem 37 37
Contamination 21 21
Contamination /Decontamination Problem 16 16
Component Missing 11 11
Use of Device Problem 9 10
Fracture 7 7
Delivered as Unsterile Product 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Material Fragmentation 6 6
Fluid/Blood Leak 5 5
Device Contamination with Chemical or Other Material 5 5
Crack 5 5
Insufficient Information 5 5
Material Frayed 4 4
Material Split, Cut or Torn 4 4
Detachment of Device or Device Component 4 4
Incomplete or Missing Packaging 4 4
Material Puncture/Hole 4 5
Manufacturing, Packaging or Shipping Problem 4 4
Tear, Rip or Hole in Device Packaging 3 3
Material Separation 3 3
Packaging Problem 3 3
Material Twisted/Bent 3 3
Improper Chemical Reaction 2 2
Inadequacy of Device Shape and/or Size 2 2
Patient Device Interaction Problem 2 2
Defective Device 2 2
Device Fell 2 2
Device Markings/Labelling Problem 2 2
Physical Resistance/Sticking 2 2
Output Problem 2 2
Fire 2 2
Device Contaminated During Manufacture or Shipping 2 2
Leak/Splash 2 2
Scratched Material 1 2
Degraded 1 1
Microbial Contamination of Device 1 1
Unraveled Material 1 1
Material Discolored 1 1
Material Too Rigid or Stiff 1 1
Moisture Damage 1 1
Defective Component 1 1
Thermal Decomposition of Device 1 1
Problem with Sterilization 1 2
Moisture or Humidity Problem 1 1
Difficult to Flush 1 1
Material Disintegration 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 169 170
Foreign Body In Patient 68 68
Insufficient Information 42 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Swelling/ Edema 10 10
Pain 6 6
Needle Stick/Puncture 4 4
Necrosis 3 3
Laceration(s) 3 3
Ambulation Difficulties 3 3
Failure of Implant 2 2
Blister 2 2
Rash 2 2
Fluid Discharge 2 2
Unspecified Infection 1 1
Impaired Healing 1 1
Superficial (First Degree) Burn 1 2
Hypersensitivity/Allergic reaction 1 1
Decreased Sensitivity 1 1
Drug Resistant Bacterial Infection 1 1
Skin Inflammation/ Irritation 1 1
Abrasion 1 1
Osteopenia/ Osteoporosis 1 1
Foreign Body Reaction 1 1
Burn(s) 1 1
Exposure to Body Fluids 1 1
Loss of Range of Motion 1 1
Numbness 1 1
Fall 1 1
Non-union Bone Fracture 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems Inc II Aug-28-2025
2 American Contract Systems Inc II Mar-14-2025
3 American Contract Systems Inc II Jul-05-2024
4 American Contract Systems Inc. II Oct-16-2025
5 American Contract Systems, Inc. II Jun-06-2025
6 American Contract Systems, Inc. II Sep-24-2024
7 American Contract Systems, Inc. II Aug-07-2024
8 American Contract Systems, Inc. II Jan-26-2024
9 American Contract Systems, Inc. III Jun-15-2023
10 American Contract Systems, Inc. II Sep-08-2022
11 American Contract Systems, Inc. II May-06-2022
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, LP II Jan-12-2026
44 Medline Industries, LP II Nov-14-2025
45 Medline Industries, LP I Nov-13-2025
46 Medline Industries, LP I Sep-26-2025
47 ROi CPS LLC II Apr-25-2023
48 ROi CPS LLC II Nov-23-2022
49 ROi CPS LLC II Feb-28-2022
50 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
51 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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