Schaerer Medical USA
Counter Traction Horizontal Perineal Post Assembly
3manufacturers in China registered for this device type
12catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Hebei (1), Sichuan (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
| Chengdu Ruinuo Meijer Medical Instrument Co., Ltd. | Chengdu | Sichuan | Manufacturer | 11 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
Record
| Listed by | Schaerer Medical USA Inc |
|---|---|
| FDA product code | JEB |
| Device type | Table, Surgical With Orthopedic Accessories, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Premarket notification | Exempt |
| Record published | 2022-09-16 |
| Record revised | 2025-02-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Sizes | Angle 90 ° |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10900 | In distribution | ||
| 10836 | In distribution | ||
| 10823 | In distribution | ||
| 10822 | In distribution | ||
| 10940 | 5 | In distribution | |
| 22111 | Angle 90 ° | In distribution | |
| 10825 | In distribution | ||
| 10824 | In distribution | ||
| 10828 | In distribution | ||
| 10821 | In distribution | ||
| 10942 | In distribution | ||
| 10210 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spica Table | Orthopediatrics, Corp | 34 |
| Alliant Biotech | Medisurge, LLC | 19 |
| Prone Perfect | Orthopediatrics, Corp | 11 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 10 |
| Table, Surgical With Orthopedic Accessories, Manual | Depuy Spine, Inc. | 9 |
| Teligen | Medos International Sàrl | 3 |
| General Instruments | Orthopediatrics, Corp | 3 |
| X-Ray Top Head Section | Jörg & Sohn GmbH | 2 |
| X-Ray Top Seat Section TS7000 | Jörg & Sohn GmbH | 2 |
| the bump | General Hospital Supply Corp. | 2 |
| Emerson Knee Bump | Biomet Orthopedics | 2 |
| X-Ray Top Back Section TS7000 | Jörg & Sohn GmbH | 2 |
Showing 12 of 32. All products under Table, Surgical With Orthopedic Accessories, Manual
Recalls
2 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 |
|---|---|---|---|---|---|
| 2016-09-27 | Class II | Nonconforming Material/Component | The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect “O” ring which may cause the cylinder to leak. | 4 surgical tables with defective floor locking cylinders wer | 2020-07-17 |
| 2016-09-27 | Class II | Nonconforming Material/Component | The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect “O” ring which may cause the cylinder to leak. | 10 replacement cylinders. | 2020-07-17 |
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.