Removal Driver
2 catalogue numbers from 6096, listed by Interventional Spine, Inc., United States, under Screwdriver. 18 manufacturers in China are registered for this product code.
18manufacturers in China registered for this device type
2catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (3), Guangdong (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Showing 12 of 18. All 18 manufacturers in China registered for Screwdriver
Record
| Listed by | Interventional Spine, Inc., United States |
|---|---|
| FDA product code | HXX |
| Device type | Screwdriver |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2015-09-21 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2016-12-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6096 | In distribution | |
| 6160-00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tecomet | Tecomet, Inc. | 939 |
| Screwdriver | Synthes Gmbh | 485 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 371 |
| Screwdriver | Medtronic Sofamor Danek, Inc. | 197 |
| Level ONE | KLS-Martin L.P. | 153 |
| Surgical Instrument | Jeil Medical Corporation | 116 |
| Invictus | Alphatec Spine, Inc. | 115 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 110 |
| Bradshaw Medical Inc. | Bradshaw Medical Inc. | 109 |
| Screwdriver | Depuy Spine, Inc. | 99 |
| Generic Surgical Instruments | CTL Medical Corporation | 93 |
| Surgical Direct | Surgical Direct, Inc. | 85 |
Showing 12 of 1,263. All products under Screwdriver
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 |
|---|---|---|---|---|---|
| 2011-02-03 | Not classified | Nonconforming Material/Component | This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this pro | 12 units | 2013-02-05 |
| 2011-02-03 | Not classified | Nonconforming Material/Component | This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this pro | 2,620 units | 2013-02-05 |
| 2011-02-03 | Not classified | Nonconforming Material/Component | This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this pro | 60 units | 2013-02-05 |
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.