Instrument
Specialty Gamma 3 Set Screwdriver
17manufacturers in China registered for this device type
1catalogue number
39510(k) clearances naming this product code
21recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-25 |
| Record revised | 2018-10-05 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-T0363NE02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113409 | 2012-02-15 |
| K102992 | 2010-12-22 |
| K101438 | 2010-06-17 |
| K083437 | 2008-12-18 |
| K082018 | 2008-10-10 |
| K081152 | 2008-06-10 |
| K063225 | 2006-12-27 |
| K060921 | 2006-04-13 |
| K051590 | 2005-07-29 |
| K051624 | 2005-07-07 |
| K043431 | 2005-02-16 |
| K043404 | 2004-12-27 |
| K042396 | 2004-10-08 |
| K034002 | 2004-01-15 |
| K032523 | 2003-10-22 |
| K032898 | 2003-10-09 |
| K032579 | 2003-08-29 |
| K032244 | 2003-08-08 |
| K023267 | 2002-12-11 |
| K022481 | 2002-08-26 |
| K022461 | 2002-08-22 |
| K021744 | 2002-06-26 |
| K020384 | 2002-05-06 |
| K021027 | 2002-04-25 |
| K021026 | 2002-04-25 |
| K020773 | 2002-04-04 |
| K020677 | 2002-03-29 |
| K014220 | 2002-01-25 |
| K013468 | 2001-11-16 |
| K013524 | 2001-11-14 |
| K012158 | 2001-08-01 |
| K011622 | 2001-06-15 |
| K011529 | 2001-06-12 |
| K010801 | 2001-04-06 |
| K003018 | 2000-12-15 |
| K993603 | 1999-11-19 |
| K993670 | 1999-11-16 |
| K992063 | 1999-09-03 |
| K990152 | 1999-03-15 |
Recalls
9 of these are 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 | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-06-30 | Class II | Labeling mix-ups | Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field. | 1 unit in total | 2017-06-21 |
| 2016-06-30 | Class II | Labeling mix-ups | Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field. | 1 unit in total | 2017-06-21 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2014-07-24 | Class II | Mixed-up of materials/components | Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label. | 484 units | 2017-06-08 |
| 2013-11-07 | Class II | Process design | Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, sterile. | 34 units | 2015-03-31 |
| 2013-05-21 | Class II | Process control | Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. | 5 units | 2014-10-14 |
| 2012-01-26 | Class II | Packaging | Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails. | 532 units. | 2013-07-17 |
| 2010-08-30 | Not classified | Other | Variations in the outer diameter of the shaft of the External Compression Device and the inner diameter of the Nail Holding Screw may make assembly of these 2 instruments not possible. | 11 | 2012-08-21 |
| 2010-08-30 | Not classified | Other | Variations in the outer diameter of the shaft of the External Compression Device and the inner diameter of the Nail Holding Screw may make assembly of these 2 instruments not possible. | 22 | 2012-08-21 |
| 2010-07-23 | Not classified | Process control | The nail has no thread for the set screw hindering insertion. | 12 units | 2012-08-06 |
| 2009-12-29 | Not classified | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. | 702 total, all sizes | 2012-08-06 |
| 2009-12-29 | Not classified | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. | 702 total, all sizes. | 2012-08-06 |
| 2009-12-29 | Not classified | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. | 702 total, all sizes. | 2012-08-06 |
| 2009-12-29 | Not classified | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. | 702 total, all sizes | 2012-08-06 |
| 2009-12-29 | Not classified | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. | 702 total, all sizes | 2012-08-06 |
| 2009-12-29 | Not classified | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. | 702 total, all sizes | 2012-08-06 |
| 2006-11-17 | Not classified | Labeling Change Control | Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm). | 1270 | 2009-08-20 |
| 2005-08-12 | Not classified | Other | The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility. | 4698 PIECES | 2006-07-20 |
| 2003-08-04 | Not classified | Other | The device does not have an oblong hole for dynamic locking as required. | 6 | 2003-09-30 |
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.