Traction Boot Liners, XLarge
Catalogue number FE00388, listed by Mizuho Orthopedic Systems, Inc., United States, under Table, Surgical With Orthopedic Accessories, Ac-Powered. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
5recalls on this code
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Kanghui Medical Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 11 |
| Baxter Medical Systems (Suzhou) Co., Ltd. | Taicang | Jiangsu | Contract manufacturer | 4 |
| Nanjing Mindray BIO-Medical Electronics Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Mizuho Orthopedic Systems, Inc., United States |
|---|---|
| FDA product code | JEA |
| Device type | Table, Surgical With Orthopedic Accessories, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-10-22 |
| Record revised | 2022-05-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FE00388 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 129 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 44 |
| Pads | Baxter Medical Systems GmbH + Co. KG | 41 |
| FusionMAX | Surgix Medical LLC | 25 |
| Orthopedic Extension | Baxter Medical Systems GmbH + Co. KG | 21 |
| TS 7500 | Baxter Medical Systems GmbH + Co. KG | 16 |
| Patient Support & Fixation | Baxter Medical Systems GmbH + Co. KG | 13 |
| IR remote control | Maquet Gmbh | 12 |
| Steris | Steris Corporation | 10 |
| DA Power Hook | United Orthopedic Corp. | 10 |
| Leg Sections | Baxter Medical Systems GmbH + Co. KG | 8 |
| Head-Positioning accessories | Baxter Medical Systems GmbH + Co. KG | 7 |
Showing 12 of 610. All products under Table, Surgical With Orthopedic Accessories, Ac-Powered
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 |
|---|---|---|---|---|---|
| 2019-10-14 | Class II | Device Design | Due to the potential for fluid ingress into the Arm which could affect the device’s electrical system and lead to a failure of the locking mechanism | 174 Arms | 2023-09-27 |
| 2012-12-17 | Class II | Process control | Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Tabl | 869 devices | 2016-04-15 |
| 2011-07-29 | Not classified | Use error | Reports of injury related incidents while using the Mizuho OSI Modular Table System. | 15,011 units | 2013-08-27 |
| 2010-03-30 | Not classified | Device Design | Device component spar gear box locks up and may result in failure of push pull tube, which may result in release of breaking and impact. | 17 units | 2011-05-17 |
| 2007-02-28 | Not classified | Software design | Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly. | 109 units | 2008-12-18 |
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.