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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
2026 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 53 53
Appropriate Term/Code Not Available 41 41
Material Integrity Problem 40 40
Contamination 33 33
Contamination /Decontamination Problem 17 17
Component Missing 12 12
Use of Device Problem 9 10
Delivered as Unsterile Product 8 8
Device Contamination with Chemical or Other Material 8 8
Fracture 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Material Fragmentation 6 6
Insufficient Information 6 6
Fluid/Blood Leak 5 5
Material Puncture/Hole 5 6
Crack 5 5
Incomplete or Missing Packaging 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Material Split, Cut or Torn 4 4
Material Twisted/Bent 4 4
Detachment of Device or Device Component 4 4
Material Frayed 4 4
Packaging Problem 4 4
Material Separation 4 4
Device Markings/Labelling Problem 3 3
Dull, Blunt 3 3
Leak/Splash 3 3
Material Disintegration 2 2
Device Fell 2 2
Defective Device 2 2
Physical Resistance/Sticking 2 2
Improper Chemical Reaction 2 2
Output Problem 2 2
Patient Device Interaction Problem 2 2
Fire 2 2
Device Contaminated During Manufacture or Shipping 2 2
Inadequacy of Device Shape and/or Size 2 2
Flaked 1 1
Electrical /Electronic Property Problem 1 1
Overheating of Device 1 1
Suction Problem 1 1
Device Reprocessing Problem 1 1
Temperature Problem 1 1
Failure to Seal 1 1
Product Quality Problem 1 1
Moisture or Humidity Problem 1 1
Problem with Sterilization 1 2
Particulates 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 204 205
Foreign Body In Patient 72 72
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 AVID Medical, Inc. I May-01-2026
2 American Contract Systems Inc II Aug-28-2025
3 American Contract Systems Inc II Mar-14-2025
4 American Contract Systems Inc II Jul-05-2024
5 American Contract Systems Inc. II Oct-16-2025
6 American Contract Systems, Inc. II Jun-06-2025
7 American Contract Systems, Inc. II Sep-24-2024
8 American Contract Systems, Inc. II Aug-07-2024
9 American Contract Systems, Inc. II Jan-26-2024
10 American Contract Systems, Inc. III Jun-15-2023
11 American Contract Systems, Inc. II Sep-08-2022
12 American Contract Systems, Inc. II May-06-2022
13 Cardinal Health 200, LLC II Feb-10-2025
14 Cardinal Health 200, LLC II Jan-15-2025
15 Cardinal Health 200, LLC II Oct-10-2023
16 MEDLINE INDUSTRIES, LP - Northfield I May-31-2025
17 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
18 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
19 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
20 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
21 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
24 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Nov-08-2024
26 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
27 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
28 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
29 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
30 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
31 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
32 MEDLINE INDUSTRIES, LP - Northfield II May-29-2024
33 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
34 MEDLINE INDUSTRIES, LP - Northfield II Aug-10-2023
35 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
36 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
37 MEDLINE INDUSTRIES, LP - Northfield II May-26-2023
38 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
39 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
40 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
41 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
42 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
43 Medline Industries Inc II Aug-09-2021
44 Medline Industries, LP II May-07-2026
45 Medline Industries, LP II Apr-30-2026
46 Medline Industries, LP II Apr-17-2026
47 Medline Industries, LP II Apr-17-2026
48 Medline Industries, LP I Apr-07-2026
49 Medline Industries, LP II Apr-01-2026
50 Medline Industries, LP II Feb-17-2026
51 Medline Industries, LP II Jan-28-2026
52 Medline Industries, LP II Jan-12-2026
53 Medline Industries, LP II Nov-14-2025
54 Medline Industries, LP I Nov-13-2025
55 Medline Industries, LP I Sep-26-2025
56 ROi CPS LLC II Apr-25-2023
57 ROi CPS LLC II Nov-23-2022
58 ROi CPS LLC II Feb-28-2022
59 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
60 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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