MeshgraftTM II Tissue Expansion System
1.5 TO 1 Dermacarrier
4manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Henan (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Yafho BIO-Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 14 |
| Jiangsu MJD Medical Technology Co., Ltd. | Taizhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Zimmer Orthopaedic Surgical Products, United States |
|---|---|
| FDA product code | FZW |
| Device type | Expander, Surgical, Skin Graft |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2020-09-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-2195-012-00 | ‘1.5 in to 1 in Expansion Ratio | In distribution |
| 00-2195-015-00 | 9 in to 1 in Expansion Ratio | In distribution |
| 00-2195-014-00 | 6 n to 1 in Expansion Ratio | In distribution |
| 00-2195-013-00 | 3 in to 1 in Expansion Ratio | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Swann Morton Ltd. | Swann Morton, Ltd. | 17 |
| Expander, Surgical, Skin Graft | Zimmer Orthopaedic Surgical Products | 9 |
| Mesh|Ex | Exsurco Medical, Inc. | 7 |
| Brennen Skin Graft Mesher | Stellen Medical, LLC | 6 |
| Aesculap | Aesculap AG | 5 |
| MT | Jiangsu MJD Medical Technology Co., Ltd. | 4 |
| Meshgraft™ | Zimmer Orthopaedic Surgical Products | 4 |
| Motiva® Inflatable Balloon | Establishment Labs S.A. | 3 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 3 |
| 4Med | 4 MED Ltd. | 3 |
| Arthrex® | Arthrex, Inc. | 3 |
| Dilator | KLS-Martin L.P. | 2 |
Showing 12 of 24. All products under Expander, Surgical, Skin Graft
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 |
|---|---|---|---|---|---|---|
| Zimmer Surgical, Inc. | UDI-DI | 2024-01-02 | Class II | Under Investigation by firm | Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary. | 76 boxes (1,520 units) US; 521 boxes (10,420 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.