ACM BioPrep
Cement Application Kit with Medium Pressurizer
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | LZN |
| Device type | Cement Obturator |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2020-11-05 (version 3) |
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 |
| Packaging | Pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0306705000 | In distribution | |
| 0306708000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clearcut | Teknimed SAS | 13 |
| Exeter | Howmedica Osteonics Corp | 11 |
| Cement Obturator | Zimmer, Inc. | 10 |
| Buck | Smith & Nephew, Inc. | 8 |
| DJO Surgical | Encore Medical, L.P. | 6 |
| Spectron | Smith & Nephew, Inc. | 6 |
| Cemstop | Teknimed SAS | 6 |
| MectaPlug | Teknimed SAS | 6 |
| Biostop | Depuy Orthopaedics, Inc. | 5 |
| Bone Plug | Howmedica Osteonics Corp | 3 |
| Perfecta | Microport Orthopedics Inc. | 2 |
| Cement Restrictor | Tornier Inc. | 2 |
Showing 12 of 17. All products under Cement Obturator
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker Instruments | UDI-DI | 2023-08-07 | Class II | Under Investigation by firm | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to compone | 231 units US; 21 units OUS |
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.