Triha+
12 catalogue numbers from Stick 5x5x20 10 units, listed by Teknimed SAS, France, under Filler, Bone Void, Calcium Compound. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
12catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Allgens Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 1 |
Record
| Listed by | Teknimed SAS, France |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2015-10-16 |
| Record revised | 2025-06-25 (version 7) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Pore size 220 µm; weight 2.85 to 18.7 g |
| Distribution end date | 2020-09-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Stick 5x5x20 10 units | Sticks 5x5x20 | In distribution |
| Granules 3x3x3 30cc | Granules 3x3x3 | In distribution |
| Granules 3x3x3 10cc | Granules 3x3x3 | In distribution |
| Chips 1-2mm 10cc | Chips 1-2mm | In distribution |
| Granules 3x3x3 5cc | Granules 3x3x3 | In distribution |
| Chips 2-5mm 20cc | Chips 2-5mm | In distribution |
| Chips 2-5mm 10cc | Chips 2-5mm | In distribution |
| Stick 5x5x20 5 units | Sticks 5x5x20 | In distribution |
| Chips 1-2mm 20cc | Chips 1-2mm | In distribution |
| Granules 6x3x2 10cc | Granules 6x3x2 | Withdrawn |
| Granules 6x3x2 5cc | Granules 6x3x2 | Withdrawn |
| Granules 6x3x2 20cc | Granules 6x3x2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synthacer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 360 |
| Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 357 |
| Biosorb | S.B.M | 65 |
| MagnetOs | Kuros Biosciences B.V | 61 |
| BioSet® | Rti Surgical, Inc. | 47 |
| Bicera® Resorbable Bone Substitute | Wiltrom Corporation Limited | 41 |
| GRAFTON®and Grafton PLUS®Demineralized Bone Matrix (DBM) | Medtronic Sofamor Danek, Inc. | 40 |
| Bicera® Resorbable Bone Substitute | Wiltrom Co., Ltd. (Chutung) | 39 |
| ChronOS | Synthes Gmbh | 39 |
| Synthacer/Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 36 |
| Inion BioRestore™ | Inion OY | 35 |
| Resorba Synthetic Bone | Biomatlante | 35 |
Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound
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 |
|---|---|---|---|---|---|
| 2006-08-31 | Not classified | Other | The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box. | 1681 units | 2012-04-23 |
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.