| Device Type ID | 4602 |
| Device Name | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LXT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4602 |
| Device | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Product Code | LXT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| CFR Regulation Number | 888.3030 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 28 |
Manufacturing, Packaging Or Shipping Problem | 23 |
Break | 18 |
Packaging Problem | 16 |
Insufficient Information | 16 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Malposition Of Device | 13 |
Difficult To Insert | 11 |
Fracture | 8 |
Device Contaminated During Manufacture Or Shipping | 7 |
Device Contamination With Chemical Or Other Material | 5 |
Device Packaging Compromised | 5 |
Device Markings / Labelling Problem | 5 |
Corroded | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Component Missing | 5 |
Physical Property Issue | 5 |
Positioning Problem | 4 |
Material Fragmentation | 3 |
Unsealed Device Packaging | 3 |
Migration Or Expulsion Of Device | 3 |
Defective Component | 2 |
Material Integrity Problem | 2 |
Pin | 2 |
Delivered As Unsterile Product | 2 |
Out-Of-Box Failure | 2 |
Separation Failure | 2 |
Mechanical Jam | 2 |
Unintended Movement | 2 |
Material Erosion | 2 |
Crack | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Incorrect Device Or Component Shipped | 1 |
Detachment Of Device Component | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Fitting Problem | 1 |
Positioning Failure | 1 |
Device Damaged By Another Device | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
Metal Shedding Debris | 1 |
Failure To Adhere Or Bond | 1 |
Material Discolored | 1 |
Migration | 1 |
Device Contamination With Body Fluid | 1 |
Bolt | 1 |
Bent | 1 |
| Total Device Problems | 236 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet, Inc. | II | Mar-08-2016 |
| 2 | Biomet, Inc. | II | Apr-14-2015 |
| 3 | Zimmer Biomet, Inc. | II | Jan-10-2019 |