Tap, Bone
23 catalogue numbers from 2360-54-55, listed by Zimmer, Inc., United States, under Tap, Bone. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
23catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (2), Zhejiang (2). 5 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| 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 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HWX |
| Device type | Tap, Bone |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-27 |
| Record revised | 2023-05-03 (version 4) |
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 |
| Sizes | Outer diameter 2.7 to 5.5 mm |
| Distribution end date | 2017-05-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2360-54-55 | Outer Diameter 5.5 mm | In distribution |
| 2360-53-45 | 4.5 mm Diameter | In distribution |
| 2360-153-27 | 2.7 mm Diameter | In distribution |
| 2360-51-35 | Outer Diameter 3.5 mm | In distribution |
| 2360-153-35 | 3.5 mm Diameter | In distribution |
| 2360-51-45 | Outer Diameter 4.5 mm | In distribution |
| 2360-51-27 | Outer Diameter 2.7 mm | In distribution |
| 2360-52-24 | 2.4 mm Diameter | In distribution |
| 2360-52-35 | Outer Diameter 3.5 mm | In distribution |
| 00-2366-050-24 | 2.4 mm Diameter | In distribution |
| 1155-11 | 4.5 mm Diameter | In distribution |
| 2360-51-55 | Outer Diameter 5.5 mm | In distribution |
| 2360-50-45 | 4.5 mm Diameter | In distribution |
| 2360-50-35 | 3.5 mm Diameter | In distribution |
| 1150-05 | In distribution | |
| 1154-05 | In distribution | |
| 2360-50-27 | 2.7 mm Diameter | In distribution |
| 2360-154-35 | Outer Diameter 3.5 mm | In distribution |
| 9366-00-062 | Withdrawn | |
| 6611-16 | Withdrawn | |
| 6611-07-02 | 6.5 mm Diameter | Withdrawn |
| 6611-07-01 | 4.5 mm Diameter | Withdrawn |
| 409-16 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 429 |
| Mariner | Seaspine Orthopedics Corporation | 285 |
| Tap, Bone | Depuy Spine, Inc. | 248 |
| Tap, Bone | Medtronic Sofamor Danek, Inc. | 228 |
| Tap, Bone | Synthes Gmbh | 191 |
| Invictus | Alphatec Spine, Inc. | 129 |
| Specials | Seaspine Orthopedics Corporation | 99 |
| Arsenal | Alphatec Spine, Inc. | 82 |
| Generic Surgical Instruments | CTL Medical Corporation | 81 |
| Mariner MIS | Seaspine Orthopedics Corporation | 78 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 72 |
| Custom | Medicrea International | 68 |
Showing 12 of 545. All products under Tap, Bone
Recalls
1 of these is 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 | Closed |
|---|---|---|---|---|
| 2019-04-08 | Class II | Under Investigation by firm | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | 2020-05-11 |
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.