| Device Type ID | 4537 |
| Device Name | Mixer, Cement, For Clinical Use |
| Regulation Description | Cement Mixer For Clinical Use. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 888.4210 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JDZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4537 |
| Device | Mixer, Cement, For Clinical Use |
| Product Code | JDZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cement Mixer For Clinical Use. |
| CFR Regulation Number | 888.4210 [🔎] |
| Device Problems | |
|---|---|
Biocompatibility | 17 |
Metal Shedding Debris | 16 |
Disassembly | 7 |
Delivered As Unsterile Product | 5 |
Leak / Splash | 5 |
Device Contaminated During Manufacture Or Shipping | 5 |
Material Fragmentation | 4 |
Break | 4 |
Loss Of Or Failure To Bond | 4 |
Tear, Rip Or Hole In Device Packaging | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Device Or Device Fragments Location Unknown | 2 |
Insufficient Information | 2 |
Delivery System Failure | 1 |
Detachment Of Device Or Device Component | 1 |
Flaked | 1 |
Pressure Problem | 1 |
Device Packaging Compromised | 1 |
Unclear Information | 1 |
Migration | 1 |
Material Disintegration | 1 |
Migration Or Expulsion Of Device | 1 |
Failure To Pump | 1 |
Component Missing | 1 |
Failure To Deliver | 1 |
Difficult Or Delayed Positioning | 1 |
Electrical /Electronic Property Problem | 1 |
| Total Device Problems | 91 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Instruments Div. Of Stryker Corporation | II | Mar-28-2018 |