Impactor Assembly
Catalogue number 202-1137, listed by Xiros Ltd, United Kingdom, under Staple Driver. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
2recalls on this code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Xiros Ltd, United Kingdom |
|---|---|
| FDA product code | HXJ |
| Device type | Staple Driver |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-05-16 |
| Record revised | 2025-04-28 (version 8) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 202-1137 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| COGNiTiON™ Staple System | Ortho Solutions Inc | 6 |
| Inion FreedomPin Instruments | Inion OY | 4 |
| Inion Otps Pin Instruments | Inion OY | 2 |
| Large UNI-Clip® | Newdeal Sas | 2 |
| In2Bones | In2Bones SAS | 1 |
| Staple Driver | Smith & Nephew, Inc. | 1 |
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 |
|---|---|---|---|---|---|
| 2006-05-17 | Not classified | Other | The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the | 89 | 2012-09-14 |
| 2006-05-17 | Not classified | Other | The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the | 10, none distributed in US | 2012-09-14 |
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.