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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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Break 41 41
Appropriate Term/Code Not Available 38 38
Material Integrity Problem 32 32
Adverse Event Without Identified Device or Use Problem 16 16
Contamination 15 15
Contamination /Decontamination Problem 15 15
Fracture 10 10
Material Fragmentation 7 7
Component Missing 7 7
Crack 5 5
Material Puncture/Hole 5 5
Fluid/Blood Leak 5 5
Material Split, Cut or Torn 4 4
Device Contamination with Chemical or Other Material 4 4
Use of Device Problem 4 4
Detachment of Device or Device Component 4 4
Material Separation 4 4
Material Frayed 3 3
Fire 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Twisted/Bent 3 3
Leak/Splash 2 2
Incomplete or Missing Packaging 2 2
Output Problem 2 2
Device Markings/Labelling Problem 2 2
Insufficient Information 2 2
Device Fell 2 2
Defective Component 2 2
Improper Chemical Reaction 2 2
Patient Device Interaction Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Packaging Problem 2 2
Failure to Seal 1 1
Temperature Problem 1 1
Dull, Blunt 1 1
Flaked 1 1
Overheating of Device 1 1
Suction Problem 1 1
Migration 1 1
Tear, Rip or Hole in Device Packaging 1 1
Product Quality Problem 1 1
Delivered as Unsterile Product 1 1
Problem with Sterilization 1 1
Thermal Decomposition of Device 1 1
Material Too Rigid or Stiff 1 1
Material Discolored 1 1
Unraveled Material 1 1
Degraded 1 1
Scratched Material 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 133 133
Foreign Body In Patient 59 59
Insufficient Information 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Pain 10 10
No Known Impact Or Consequence To Patient 9 9
Needle Stick/Puncture 4 4
Blister 3 3
Laceration(s) 3 3
No Consequences Or Impact To Patient 3 3
Ambulation Difficulties 3 3
Superficial (First Degree) Burn 2 2
Failure of Implant 2 2
No Code Available 2 2
Necrosis 2 2
Burn(s) 2 2
Rash 2 2
Fluid Discharge 2 2
Extravasation 2 2
Device Embedded In Tissue or Plaque 2 2
Impaired Healing 1 1
Wound Dehiscence 1 1
Hypersensitivity/Allergic reaction 1 1
Decreased Sensitivity 1 1
Seizures 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Abrasion 1 1
Osteopenia/ Osteoporosis 1 1
Foreign Body Reaction 1 1
Weakness 1 1
Exposure to Body Fluids 1 1
Loss of Range of Motion 1 1
Swelling 1 1
Numbness 1 1
Fall 1 1
Reaction 1 1
Non-union Bone Fracture 1 1
Swelling/ Edema 1 1
Pulmonary Embolism 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 Sep-24-2024
5 American Contract Systems, Inc. II Aug-07-2024
6 American Contract Systems, Inc. II Jan-26-2024
7 American Contract Systems, Inc. III Jun-15-2023
8 American Contract Systems, Inc. II Sep-08-2022
9 American Contract Systems, Inc. II May-06-2022
10 Avid Medical, Inc. II Mar-19-2020
11 Cardinal Health 200, LLC II Feb-10-2025
12 Cardinal Health 200, LLC II Jan-15-2025
13 Cardinal Health 200, LLC II Oct-10-2023
14 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
15 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
16 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
17 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Nov-08-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
24 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
26 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
27 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
28 MEDLINE INDUSTRIES, LP - Northfield II May-29-2024
29 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
30 MEDLINE INDUSTRIES, LP - Northfield II Aug-10-2023
31 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
32 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
33 MEDLINE INDUSTRIES, LP - Northfield II May-26-2023
34 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
35 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
36 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
37 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
38 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
39 Medline Industries Inc II Aug-09-2021
40 Medline Industries Inc II Feb-11-2020
41 ROi CPS LLC II Apr-25-2023
42 ROi CPS LLC II Nov-23-2022
43 ROi CPS LLC II Feb-28-2022
44 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
45 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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