PST LSS Brch Hndle
Catalogue number SSI006885, listed by Zimmer, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Guangdong (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 |
|---|---|---|---|---|
| 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 Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Changzhou Master Precision Tool Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HTQ |
| Device type | Broach |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-03-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSI006885 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 132 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 119 |
| DJO Surgical | DJO, LLC | 89 |
| iNSitu™ Hip System | Nextstep Arthropedix | 84 |
| OrthoMedFlex | Orthomedflex LLC | 63 |
| Anthology | Smith & Nephew, Inc. | 56 |
| LinkBio Instrument | Link BIO Corp | 53 |
| Profemur® | Microport Orthopedics Inc. | 47 |
| Calix Spinal Implant System | Xtant Medical Holdings, Inc. | 40 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 39 |
| Polar | Smith & Nephew, Inc. | 36 |
| Integra® | Ascension Orthopedics, Inc. | 36 |
Showing 12 of 216. All products under Broach
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 |
|---|---|---|---|---|---|
| 2009-04-29 | Not classified | Device Design | The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents attachment of another handle to retrieve the device. | 435 | 2010-10-08 |
| 2009-03-13 | Not classified | Finished device change control | The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions. | 37 | 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.