Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 104 104

Device Problems MDRs with this Device Problem Events in those MDRs
Break 43 43
Material Integrity Problem 41 41
Appropriate Device Problem Term/Code Not Available 41 41
Contamination 27 27
Contamination /Decontamination Problem 13 13
Use of Device Problem 11 11
Leak/Splash 10 10
Material Separation 10 10
Adhesive Too Strong 8 8
Insufficient Device Problem Information 8 8
Fracture 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Delivered as Unsterile Product 6 6
Material Frayed 5 5
Material Split, Cut or Torn 5 5
Crack 5 5
Dull, Blunt 5 5
Material Fragmentation 5 5
Material Disintegration 4 4
Fluid/Blood Leak 4 4
Loose or Intermittent Connection 4 4
Material Twisted/Bent 4 4
Material Puncture/Hole 3 3
Difficult to Remove 3 3
Electrical /Electronic Property Problem 3 3
Detachment of Device or Device Component 3 3
Fire 2 2
Premature Activation 2 2
Patient Device Interaction Problem 2 2
Improper Chemical Reaction 2 2
Failure to Seal 1 1
Extra Components 1 1
Temperature Problem 1 1
Corroded 1 1
Overheating of Device 1 1
Suction Problem 1 1
Unexpected Therapeutic Results 1 1
Nonstandard Device 1 1
Device Reprocessing Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Tear, Rip or Hole in Device Packaging 1 1
Inadequacy of Device Shape and/or Size 1 1
Product Quality Problem 1 1
Packaging Problem 1 1
Moisture or Humidity Problem 1 1
Problem with Sterilization 1 2
Particulates 1 1
Thermal Decomposition of Device 1 1
Component Missing 1 1
Material Too Rigid or Stiff 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 244 245
Foreign Body In Patient 73 73
Insufficient Information 42 43
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 12 12
Skin Tears 11 11
Swelling/ Edema 10 10
Pain 6 6
Loss of fracture reduction 6 6
Unspecified Infection 4 4
Needle Stick/Puncture 4 4
Wound Dehiscence 3 3
Necrosis 3 3
Ambulation or Postural Difficulties 3 3
Laceration(s) 3 3
Nonunion/Delayed-union Bone Fracture 3 3
Fluid Discharge 3 3
Damage to Ligament(s) 2 2
Impaired Healing 2 2
Failure of Implant 2 2
Implant Pain 2 2
Blister 2 2
Medical device site infection 2 2
Burn(s) 2 2
Rash 2 2
Superficial (First Degree) Burn 1 2
Hypersensitivity/Allergic reaction 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
Post Operative Wound Infection 1 1
Exposure to Body Fluids 1 1
Erythema 1 1
Loss of Range of Motion 1 1
Numbness 1 1
Hyporesponsive to stimuli 1 1
Ecchymosis 1 1
Fall 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AVID Medical, Inc. II Aug-28-2026
2 AVID Medical, Inc. II Jun-11-2026
3 AVID Medical, Inc. I May-01-2026
4 American Contract Systems Inc II Aug-20-2026
5 American Contract Systems Inc II Aug-28-2025
6 American Contract Systems Inc II Mar-14-2025
7 American Contract Systems Inc II Jul-05-2024
8 American Contract Systems Inc. II Oct-16-2025
9 American Contract Systems, Inc. II Jun-06-2025
10 American Contract Systems, Inc. II Sep-24-2024
11 American Contract Systems, Inc. II Aug-07-2024
12 American Contract Systems, Inc. II Jan-26-2024
13 American Contract Systems, Inc. III Jun-15-2023
14 American Contract Systems, Inc. II Sep-08-2022
15 American Contract Systems, Inc. II May-06-2022
16 Cardinal Health 200, LLC II Sep-03-2026
17 Cardinal Health 200, LLC II Aug-13-2026
18 Cardinal Health 200, LLC II Feb-10-2025
19 Cardinal Health 200, LLC II Jan-15-2025
20 Cardinal Health 200, LLC II Oct-10-2023
21 MEDLINE INDUSTRIES, LP - Northfield I May-31-2025
22 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
23 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
24 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
25 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
26 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
27 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
28 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
29 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
30 MEDLINE INDUSTRIES, LP - Northfield II Nov-08-2024
31 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
32 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
33 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
34 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
35 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
36 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
37 MEDLINE INDUSTRIES, LP - Northfield II May-29-2024
38 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
39 MEDLINE INDUSTRIES, LP - Northfield II Aug-10-2023
40 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
41 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
42 MEDLINE INDUSTRIES, LP - Northfield II May-26-2023
43 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
44 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
45 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
46 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
47 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
48 Medline Industries Inc II Aug-09-2021
49 Medline Industries, LP II Aug-31-2026
50 Medline Industries, LP II Aug-31-2026
51 Medline Industries, LP II Aug-26-2026
52 Medline Industries, LP II Aug-21-2026
53 Medline Industries, LP II Jul-23-2026
54 Medline Industries, LP I Jul-23-2026
55 Medline Industries, LP I Jul-22-2026
56 Medline Industries, LP II Jul-15-2026
57 Medline Industries, LP II Jun-25-2026
58 Medline Industries, LP II Jun-17-2026
59 Medline Industries, LP II Jun-12-2026
60 Medline Industries, LP I May-28-2026
61 Medline Industries, LP II May-07-2026
62 Medline Industries, LP II Apr-30-2026
63 Medline Industries, LP II Apr-17-2026
64 Medline Industries, LP II Apr-17-2026
65 Medline Industries, LP I Apr-07-2026
66 Medline Industries, LP II Apr-01-2026
67 Medline Industries, LP II Feb-17-2026
68 Medline Industries, LP II Jan-28-2026
69 Medline Industries, LP II Jan-12-2026
70 Medline Industries, LP II Nov-14-2025
71 Medline Industries, LP I Nov-13-2025
72 Medline Industries, LP I Sep-26-2025
73 ROi CPS LLC II Apr-25-2023
74 ROi CPS LLC II Nov-23-2022
75 ROi CPS LLC II Feb-28-2022
76 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
77 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
78 Windstone Medical Packaging, Inc. II Jul-24-2026
-
-