Wrench
14 catalogue numbers from 1148-05, listed by Zimmer, Inc., United States, under Wrench. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
14catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Shandong (2). 6 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 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
Showing 12 of 14. All 14 manufacturers in China registered for Wrench
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HXC |
| Device type | Wrench |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-26 |
| Record revised | 2023-05-03 (version 5) |
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 |
| Distribution end date | 2017-06-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1148-05 | 5/64 Inch Size | In distribution |
| 195-02 | In distribution | |
| 4600-50-03 | In distribution | |
| 1148-08 | 3.2 mm (1/8 Inch) Size | In distribution |
| 5120-73-01 | In distribution | |
| 6631-55 | In distribution | |
| 409-15 | Withdrawn | |
| 1148-06 | 3/32 Inch Size | Withdrawn |
| 31-8106-48 | Withdrawn | |
| 7712-55 | Withdrawn | |
| 9354-01-601 | Withdrawn | |
| 9354-01-600 | Withdrawn | |
| 6601-31 | 3/8 Inch Sq. Drive Torque Wrench Adaptor | Withdrawn |
| 6601-30 | 3/8 Inch Sq., 0-200 Inch-lb. | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 85 |
| Wrench | Synthes Gmbh | 80 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 26 |
| Smart Correction | Wishbone Medical Inc. | 25 |
| Pinnacle Gription TF | Depuy (Ireland) | 23 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 21 |
| Mega Plus Spine System | BK Meditech Co., Ltd. | 20 |
| Kalitec Universal Instruments | Kalitec Direct, LLC | 19 |
| Medtronic Resuable Instruments | Medtronic Sofamor Danek, Inc. | 17 |
| X FIX | Biomet Orthopedics | 15 |
| Global Steptech APG | Depuy Orthopaedics, Inc. | 14 |
| Pinnacle | Depuy (Ireland) | 13 |
Showing 12 of 388. All products under Wrench
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 |
|---|---|---|---|---|---|
| 2008-11-07 | Not classified | Process control | Some of the torque wrenches apply less than the minimum torque to the screw locking cap when the torque indicators are aligned as described in the surgical technique. | 76 | 2009-12-22 |
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.