Miller™
Catalogue number 5069-52, listed by Zimmer, Inc., United States, under Evacuator, Vapor, Cement Monomer. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | JDY |
| Device type | Evacuator, Vapor, Cement Monomer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4220 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-10 |
| Record revised | 2023-05-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5069-52 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Evacuator, Vapor, Cement Monomer | Zimmer Orthopaedic Surgical Products | 5 |
| Easymix® compressed air hose | Osartis Gmbh | 2 |
| HNM Medical | HNM Stainless, LLC. | 2 |
| SmartMix Vacuum Footpump and Airhose | Summit Medical LLC | 1 |
| Palamix® | Heraeus Medical LLC | 1 |
| Easymix® vacuum pump I | Osartis Gmbh | 1 |
| Summit Medical High Vacuum Footpump + Air Hose | Summit Medical LLC | 1 |
| Easymix® vacuum pump II | Osartis Gmbh | 1 |
| SmartMix CemVac Dual Vacuum Footpump & Airhose | Summit Medical LLC | 1 |
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 |
|---|---|---|---|---|---|
| 2008-06-30 | Not classified | Process change control | The cartridge is brittle and at increased risk of breakage. | 257 packages of 10 kits each. | 2009-11-12 |
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.