Revolution
Cement Gun
3manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | KIH |
| Device type | Dispenser, Cement |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4200 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2025-06-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0606600000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dispenser, Cement | Medtronic Sofamor Danek, Inc. | 14 |
| Pressurizer | Adler Ortho SpA | 11 |
| DJO Surgical | Encore Medical, L.P. | 7 |
| Vortex | Smith & Nephew, Inc. | 6 |
| Dispenser, Cement | Zimmer, Inc. | 5 |
| Miller™ | Zimmer, Inc. | 5 |
| Dispenser, Cement | Synthes (U.S.A.) LP | 5 |
| SpineJack | Stryker GmbH | 4 |
| Kyphon® Cement Delivery System | Medtronic Sofamor Danek, Inc. | 4 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 4 |
| PowerFlo | Zimmer, Inc. | 4 |
| Palamix® | Heraeus Medical LLC | 3 |
Showing 12 of 111. All products under Dispenser, Cement
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-01-13 | Not classified | Mixed-up of materials/components | The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. The product was labeled as Flat Proximal Pressurizer P/N 0206-556-000 while the product inside th | 10 boxes (60 units) | 2013-07-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.