Biofoam
Subtalar Trial
22manufacturers in China registered for this device type
26catalogue numbers in this listing
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-10-01 |
| Record revised | 2022-03-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 4.5 to 12 mm; length 16 to 24 mm; width 10 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 46S51812 | Height 12 mm | In distribution |
| 47S52210 | Size: 22mm x 22mm x 10mm | In distribution |
| 46S02405 | Length 24 mm | In distribution |
| 46S02055 | Height 5.5 mm | In distribution |
| 46600524 | Size: 14 x 10 x 24 x 5 x 2.5mm | In distribution |
| 47S52208 | Size: 22mm x 22mm x 8mm | In distribution |
| 46600522 | Size: 14 x 10 x 22 x 5 x 2.5mm | In distribution |
| 46001520 | Size: 20mm | In distribution |
| 46641020 | Size: 20 x 20 x 10mm | In distribution |
| 47S51808 | Size: 18mm x 18mm x 8mm | In distribution |
| 46S52010 | Size: 20 x 20mm | In distribution |
| 46S51810 | Size: 18 x 18mm | In distribution |
| 46S01306 | Height 6 mm | In distribution |
| 46S02475 | Height 7.5 mm | In distribution |
| 46607524 | Size: 14 x 10 x 24 x 7.5 x 2.5mm | In distribution |
| 46S02205 | Height 5 mm | In distribution |
| 46S01525 | Size: 25mm | In distribution |
| 46S02275 | Width 14 mm | In distribution |
| 46S02095 | Height 9.5 mm | In distribution |
| 47S01306 | Size: 13mm x 17mm x 6mm | In distribution |
| 47S01312 | Size: 13mm x 17mm x 12mm | In distribution |
| 46001310 | Size: 10mm | In distribution |
| 47S02085 | Size: 20mm x 16mm x 8.5mm | In distribution |
| 46S01655 | Height 5.5 mm | In distribution |
| 46S01645 | Length 16 mm | In distribution |
| 46641222 | Size: 22 x 20 x 12mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
Recalls
40 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 |
|---|---|---|---|---|---|
| 2023-04-10 | Class II | Employee error | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. | 50 units | |
| 2023-04-10 | Class II | Employee error | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. | 41 units | |
| 2023-02-02 | Class II | Employee error | Stryker has identified an issue that impacts two specific lots of CLAW” II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contai | 10 units | |
| 2023-02-02 | Class II | Employee error | Stryker has identified an issue that impacts two specific lots of CLAW” II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contai | 4 units | |
| 2022-02-15 | Class II | Process control | An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw. | 1 package | 2022-10-05 |
| 2022-02-09 | Class II | Packaging process control | Product was labelled with the incorrect manufacturing and distribution dates. | 12 units | 2024-01-25 |
| 2021-12-03 | Class II | Under Investigation by firm | Incorrect product is contained in the packaging. | 22 units | |
| 2021-12-03 | Class II | Under Investigation by firm | The incorrect product is contained in the packaging. | 23 units | |
| 2021-12-03 | Class II | Under Investigation by firm | The incorrect product is contained in the packaging. | 250 units | |
| 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 30 units | 2020-11-03 |
| 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 42 units | 2020-11-03 |
| 2015-07-21 | Class II | Employee error | These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction. | 5687 units | 2018-08-01 |
| 2015-07-21 | Class II | Employee error | These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction. | 107 units | 2018-08-01 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 167 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 100 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 233 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. | 52 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. | 92 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 142 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 242 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 270 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 128 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 138 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 102 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 372 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. | 51 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. | 151 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 308 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 172 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 148 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 102 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 301 units | 2018-08-05 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 0 | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 50 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 1127 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 400 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 9 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 178 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 18 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 66 units | 2018-06-15 |
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.