Healicoil
Healicoil Regenesorb 4.75 MM Threaded Dilator, Reusable
53manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-08-29 |
| Record revised | 2023-09-07 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72203709 | In distribution | |
| 72203710 | In distribution | |
| 72202621 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K001507 | 2000-06-14 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2020-06-29 | Class II | Process design | The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part. | 3 units | 2022-02-18 |
| 2019-10-07 | Class II | Process control | LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress. | 116 devices | 2023-03-08 |
| 2019-01-07 | Class II | Process control | The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble. | 72 units | 2020-09-17 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 927 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 3435 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 8195 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 44 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 1203 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 739 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 867 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 1434 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 1300 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 1693 units | 2015-09-22 |
| 2011-07-07 | Not classified | Nonconforming Material/Component | Shaft tip (casting) does not meet the SNE 416 specification, which could result in rusting of the Tendon Strippers | 570 units | 2015-07-23 |
| 2010-04-20 | Not classified | Process control | Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side | 12 units | 2011-12-07 |
| 2009-01-22 | Not classified | Process design | Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long. | 99 units | 2011-08-18 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 2 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 4 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 1 unit | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 10 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 1 unit | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 8 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 21 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 1 unit | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 42 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 10 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 1 unit | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 8 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 10 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 30 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 1 unit | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 6 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 12 units | 2010-02-02 |
| 2007-07-12 | Not classified | Packaging process control | The carton label may not reflect the correct size of the acetabular cup. | 9 units | 2010-02-02 |
| 2007-03-13 | Not classified | Other | The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup. | 1 unit | 2011-10-28 |
| 2007-03-13 | Not classified | Other | The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup. | 1 unit | 2011-10-28 |
| 2007-03-13 | Not classified | Other | The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup. | 4 units | 2011-10-28 |
| 2007-03-13 | Not classified | Other | The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup. | 1 unit | 2011-10-28 |
| 2007-03-13 | Not classified | Other | The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup. | 1 unit | 2011-10-28 |
| 2006-08-29 | Not classified | Other | Tibial punches were not manufactured to specification and could break at the tip during use. | 4800 units | 2010-04-12 |
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.