AutoPlex, VertaPlex
M4 Cement Mixer for Manifold with HV Bone Cement
14manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code
13recalls on this code
Who Else Makes It
Concentrated in Guangdong (5), Hebei (2), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
Showing 12 of 14. All 14 manufacturers in China registered for Mixer, Cement, For Clinical Use
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | JDZ |
| Device type | Mixer, Cement, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4210 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-03 |
| Record revised | 2021-11-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment humidity 10 to 75 % RH; Handling environment temperature -20 to 40 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Pack of 2 |
| Sizes | Length 5 in; needle gauge 13 G |
| Distribution end date | 2021-07-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0607687000 | In distribution | |
| 0707000000 | In distribution | |
| 0707002000 | In distribution | |
| 0605685000 | Length 5.0 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premium Plus | Premium Plus International Limited | 26 |
| DJO Surgical | Encore Medical, L.P. | 23 |
| Mixer, Cement, For Clinical Use | Stryker GmbH | 22 |
| Revolution | Stryker GmbH | 17 |
| Cleanest | Guangzhou Clean Medical Products Manufacturing Corp | 15 |
| Midway Select | Midway Dental Supply, LLC | 8 |
| Mixor | Smith & Nephew, Inc. | 7 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 6 |
| Mini-Bowls | Pulpdent Corporation | 4 |
| Quick-Vac® Vacuum Mixing Bowl | Summit Medical LLC | 4 |
| Henry Schein | Henry Schein, Inc. | 3 |
| PicoMix Syringe | G21 SRL | 3 |
Showing 12 of 84. All products under Mixer, Cement, For Clinical Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K912190 | 1991-08-29 |
| K854077 | 1986-01-31 |
| K760617 | 1976-10-05 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 30 | 2019-04-16 |
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 384 | 2019-04-16 |
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 444 | 2019-04-16 |
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 1542 | 2019-04-16 |
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 708 | 2019-04-16 |
| 2017-11-09 | Class II | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 732 | 2019-04-16 |
| 2013-11-01 | Class II | Nonconforming Material/Component | On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product was going to be placed in the pouch to be sealed, the manufacturing operator not | 87 boxes (522 each) | 2014-02-10 |
| 2011-11-30 | Not classified | Component change control | Product was packaged with a four inch needle in stead of the correct five inch needle. There is a potential that the needle may not be able to reach the fracture site, which may require additional medical intervention. In addition, if the | 11 kits of the 192 manufactured contain the wrong needle siz | 2012-08-14 |
| 2008-02-13 | Not classified | Labeling Change Control | Mis-labeing; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy) | 953 boxes Recalls Z-1192-1195-2008 | 2008-12-30 |
| 2008-02-13 | Not classified | Labeling Change Control | Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy) | 953 boxes Recalls Z-1192-1195-2008 | 2008-12-30 |
| 2008-02-13 | Not classified | Labeling Change Control | Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy) | 953 boxes Recalls Z-1192-1195-2008 | 2008-12-30 |
| 2008-02-13 | Not classified | Labeling Change Control | Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy) | 953 boxes Recalls Z-1192-1195-2008 | 2008-12-30 |
| 2008-01-10 | Not classified | Nonconforming Material/Component | Sterility may be compromised, as the packaging may have channels in the packaging seal. | 25 boxes of 6 each | 2008-07-31 |
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.