| Device Type ID | 4543 |
| Device Name | Dispenser, Cement |
| Regulation Description | Cement Dispenser. |
| 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 | 888.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KIH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4543 |
| Device | Dispenser, Cement |
| Product Code | KIH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cement Dispenser. |
| CFR Regulation Number | 888.4200 [🔎] |
| Device Problems | |
|---|---|
Break | 11 |
Adverse Event Without Identified Device Or Use Problem | 10 |
Mechanical Jam | 4 |
Appropriate Term/Code Not Available | 3 |
Fracture | 3 |
Device Operates Differently Than Expected | 2 |
Device Handling Problem | 2 |
Partial Blockage | 2 |
Leak / Splash | 2 |
Plunger | 1 |
Fluid Leak | 1 |
Defective Device | 1 |
Noise, Audible | 1 |
Gears | 1 |
Device Damaged Prior To Use | 1 |
Device Operational Issue | 1 |
Failure To Advance | 1 |
Material Integrity Problem | 1 |
No Display / Image | 1 |
Use Of Device Problem | 1 |
Inaccurate Dispensing | 1 |
Extrusion | 1 |
| Total Device Problems | 52 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BIOMET FRANCE S.A.R.L. | II | Jun-10-2015 |
| 2 | Orthovita, Inc., DBA Stryker Orthobiologics. | II | Sep-16-2015 |
| 3 | Zimmer Biomet, Inc. | II | Apr-01-2019 |