Acufex
Tibial Anchor Drill Guide. Quickly AND Accurately Produces A 25 MM Deep Perpendicular Hole When Used With THE Tibial Anchor Drill BIT REF 014925. FOR USE IN Hard Bone Without THE Tibial…
Tibial Anchor Drill Guide. Quickly AND Accurately Produces A 25 MM Deep Perpendicular Hole When Used With THE Tibial Anchor Drill BIT REF 014925. FOR USE IN Hard Bone Without THE Tibial Anchor Drill
14manufacturers in China registered for this device type
260catalogue numbers in this listing
26recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Shandong (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 |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Zhongshan Saxin Electric Heating Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 27 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
Showing 12 of 14. All 14 manufacturers in China registered for Accessories, Arthroscopic
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | NBH |
| Device type | Accessories, Arthroscopic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-08-30 |
| Record revised | 2023-09-07 (version 11) |
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 |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5 |
| Distribution end date | 2025-07-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 012059 | In distribution | ||
| 012016 | In distribution | ||
| 72201975 | In distribution | ||
| 72201240 | In distribution | ||
| 72205123 | In distribution | ||
| 72203427 | In distribution | ||
| 012035 | In distribution | ||
| 012053 | In distribution | ||
| 72203434 | In distribution | ||
| 72205115 | In distribution | ||
| 7207049 | In distribution | ||
| 7207000 | In distribution | ||
| 012055 | In distribution | ||
| 7207048 | In distribution | ||
| 014723 | In distribution | ||
| 71935073 | In distribution | ||
| 012046 | In distribution | ||
| 71935072 | In distribution | ||
| 72201735 | 3 | In distribution | |
| 010815 | In distribution | ||
| 012060 | In distribution | ||
| 7207200 | In distribution | ||
| 72201883 | In distribution | ||
| 72203439 | In distribution | ||
| 7207050 | In distribution | ||
| 010803 | In distribution | ||
| 7207540 | In distribution | ||
| 7207294 | In distribution | ||
| 012012 | In distribution | ||
| 010806 | In distribution | ||
| 72201974 | In distribution | ||
| 72201973 | In distribution | ||
| 72201716 | In distribution | ||
| 7207601 | In distribution | ||
| 72201978 | In distribution | ||
| 7207599 | In distribution | ||
| 010800 | In distribution | ||
| 012037 | In distribution | ||
| 012030 | In distribution | ||
| 72203450 | In distribution | ||
| 7207552 | In distribution | ||
| 7207602 | In distribution | ||
| 72201713 | In distribution | ||
| 72201733 | In distribution | ||
| 72203438 | In distribution | ||
| 7205525 | In distribution | ||
| 012045 | In distribution | ||
| 72203453 | In distribution | ||
| 72203426 | In distribution | ||
| 7207051 | In distribution | ||
| 013977 | In distribution | ||
| 7207598 | In distribution | ||
| 72201244 | In distribution | ||
| 72201243 | In distribution | ||
| 010640 | In distribution | ||
| 72203430 | In distribution | ||
| 010001 | In distribution | ||
| 72201971 | In distribution | ||
| 012013 | In distribution | ||
| 72201969 | In distribution | ||
| 014843 | In distribution | ||
| 72201715 | In distribution | ||
| 010814 | In distribution | ||
| 7207545 | In distribution | ||
| 7205517 | In distribution | ||
| 7209494 | In distribution | ||
| 7208679 | In distribution | ||
| E0015282-1 | In distribution | ||
| 72201732 | In distribution | ||
| 012047 | In distribution | ||
| 72203442 | In distribution | ||
| 014844 | In distribution | ||
| 010801 | In distribution | ||
| 72201247 | In distribution | ||
| 72202361 | In distribution | ||
| 3856 | In distribution | ||
| 7207760 | In distribution | ||
| E0015939-3 | In distribution | ||
| 012205 | In distribution | ||
| 012031 | In distribution | ||
| 010807 | In distribution | ||
| 012015 | In distribution | ||
| 010817 | In distribution | ||
| 010906 | In distribution | ||
| 72201250 | In distribution | ||
| 7207600 | In distribution | ||
| 013219D | In distribution | ||
| 72201717 | In distribution | ||
| 72203169 | In distribution | ||
| 010610 | In distribution | ||
| 012029 | In distribution | ||
| 7209878 | In distribution | ||
| 010901 | In distribution | ||
| 010912 | In distribution | ||
| 72203447 | In distribution | ||
| 012040 | In distribution | ||
| 72202360 | In distribution | ||
| 7207047 | In distribution | ||
| 012054 | In distribution | ||
| 013219 | In distribution | ||
| 72203428 | In distribution | ||
| 7209491 | In distribution | ||
| 010802 | In distribution | ||
| 72203445 | In distribution | ||
| 72201972 | In distribution | ||
| 7205518 | In distribution | ||
| 72205122 | In distribution | ||
| 7207059 | In distribution | ||
| 7207282 | In distribution | ||
| 010003 | In distribution | ||
| 010816 | In distribution | ||
| 3312 | In distribution | ||
| 72201246 | In distribution | ||
| 72203425 | In distribution | ||
| 72203440 | In distribution | ||
| 010812 | In distribution | ||
| 012032 | In distribution | ||
| 7207283 | In distribution | ||
| 012014 | In distribution | ||
| 7210758 | In distribution | ||
| 7209492 | In distribution | ||
| E0015783-1 | In distribution | ||
| 010813 | In distribution | ||
| 012061 | In distribution | ||
| 010630 | In distribution | ||
| 012203 | In distribution | ||
| 72203435 | In distribution | ||
| 7207083 | In distribution | ||
| 7209134 | In distribution | ||
| 72203436 | In distribution | ||
| 72201242 | In distribution | ||
| 72201241 | In distribution | ||
| 7207737 | In distribution | ||
| 010660 | In distribution | ||
| 012039 | In distribution | ||
| 72203451 | In distribution | ||
| 012202 | In distribution | ||
| 72201245 | In distribution | ||
| 012033 | In distribution | ||
| 010600 | In distribution | ||
| 012043 | In distribution | ||
| 010161 | In distribution | ||
| 72201886 | In distribution | ||
| 72203432 | In distribution | ||
| 7205521 | In distribution | ||
| 7205522 | In distribution | ||
| 7207295 | In distribution | ||
| 72203446 | In distribution | ||
| 7207058 | In distribution | ||
| 012042 | In distribution | ||
| 7207057 | In distribution | ||
| 7207181 | In distribution | ||
| 010680 | In distribution | ||
| 72201621 | In distribution | ||
| 014724 | In distribution | ||
| 012058 | In distribution | ||
| 72203444 | In distribution | ||
| 7207544 | In distribution | ||
| E0015242-1 | In distribution | ||
| 72201737 | In distribution | ||
| 72201248 | In distribution | ||
| 72203437 | In distribution | ||
| 72201734 | In distribution | ||
| 72201376 | In distribution | ||
| 012052 | In distribution | ||
| 012204 | In distribution | ||
| 012044 | In distribution | ||
| 72201736 | In distribution | ||
| 72201249 | In distribution | ||
| 72203443 | In distribution | ||
| 7207053 | In distribution | ||
| 7207662 | In distribution | ||
| 7205519 | In distribution | ||
| 72201970 | In distribution | ||
| 72201714 | In distribution | ||
| 010913 | In distribution | ||
| 7207054 | In distribution | ||
| 012038 | In distribution | ||
| 012201 | In distribution | ||
| 72205180 | In distribution | ||
| 010900 | In distribution | ||
| 72205117 | In distribution | ||
| 012041 | In distribution | ||
| E0015939-1 | In distribution | ||
| 012051 | In distribution | ||
| 72201377 | In distribution | ||
| 010650 | In distribution | ||
| E0015939-2 | In distribution | ||
| 7207733 | In distribution | ||
| 012034 | In distribution | ||
| 72201885 | In distribution | ||
| 7207734 | In distribution | ||
| 72203433 | In distribution | ||
| 012048 | In distribution | ||
| 72203431 | In distribution | ||
| 7207735 | In distribution | ||
| 7207046 | In distribution | ||
| 7207281 | In distribution | ||
| 010002 | In distribution | ||
| 012011 | In distribution | ||
| 72201884 | In distribution | ||
| 7207736 | In distribution | ||
| 7205524 | In distribution | ||
| 6901029 | In distribution | ||
| 7208685 | In distribution | ||
| 012036 | In distribution | ||
| 7207296 | In distribution | ||
| 010907 | In distribution | ||
| 72201378 | In distribution | ||
| 010525 | In distribution | ||
| 7207201 | In distribution | ||
| 72203441 | In distribution | ||
| 010620 | In distribution | ||
| 72205116 | In distribution | ||
| 7207060 | In distribution | ||
| 72203429 | In distribution | ||
| 72201976 | In distribution | ||
| 7207052 | In distribution | ||
| 72205114 | In distribution | ||
| 7207672 | In distribution | ||
| 7207055 | In distribution | ||
| 7210753 | In distribution | ||
| 72201379 | In distribution | ||
| 72201977 | In distribution | ||
| 010121 | In distribution | ||
| 012020 | In distribution | ||
| 7204869 | In distribution | ||
| 7207659 | Withdrawn | ||
| 3134136 | Withdrawn | ||
| 7204873 | Withdrawn | ||
| 3134265 | Withdrawn | ||
| 7207665 | Withdrawn | ||
| 7207660 | Withdrawn | ||
| 72202487 | Withdrawn | ||
| 72200719 | Withdrawn | ||
| 72201850 | Withdrawn | ||
| 3134282 | Withdrawn | ||
| 7207663 | Withdrawn | ||
| 7207530 | Withdrawn | ||
| 014779 | Withdrawn | ||
| 7210754 | Withdrawn | ||
| 7207670 | Withdrawn | ||
| 7210755 | Withdrawn | ||
| 7207667 | Withdrawn | ||
| 7207661 | Withdrawn | ||
| 7207671 | Withdrawn | ||
| 7207673 | Withdrawn | ||
| 7207666 | Withdrawn | ||
| 7207668 | Withdrawn | ||
| 6901154 | Withdrawn |
Showing 250 of 260 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 1,020 |
| Accessories, Arthroscopic | Smith & Nephew, Inc. | 913 |
| Millennium | Avalign Technologies, Inc. | 335 |
| Surgical Direct | Surgical Direct, Inc. | 312 |
| AED | National Advanced Endoscopy Devices, Inc. | 266 |
| Elmed | Elmed, Inc. | 262 |
| Razek Equipamentos | Razek Equipamentos Ltda | 235 |
| Sports Med Instruments | Medacta International SA | 175 |
| Conmed | ConMed Corporation | 159 |
| Accessories, Arthroscopic | Richard Wolf Gmbh | 153 |
| Vertebris | Richard Wolf Gmbh | 135 |
| Accessories, Arthroscopic | Stryker GmbH | 133 |
Showing 12 of 598. All products under Accessories, Arthroscopic
Recalls
5 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 |
|---|---|---|---|---|---|
| 2020-09-21 | Class II | Process control | The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation. | 143 units | 2024-03-22 |
| 2016-06-15 | Class II | Package design/selection | The device could be subject to breaches of its sterile packaging. | 563 | 2021-03-22 |
| 2016-01-11 | Class II | Device Design | Blade exhibiting fracture during hip arthroscopy procedures | 69043 units | 2017-09-18 |
| 2013-07-30 | Class II | Under Investigation by firm | During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up d | 203 units | 2021-02-24 |
| 2013-04-04 | Class II | Employee error | Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver. | 9 | 2021-03-22 |
| 2010-04-29 | Not classified | Component design/selection | Endofemoral Aimer tip may separate due to failure of the soldered joint | 577 units | 2012-05-09 |
| 2010-04-29 | Not classified | Component design/selection | Endofemoral Aimer tip may separate due to failure of the soldered joint | 5 units | 2012-05-09 |
| 2010-04-29 | Not classified | Component design/selection | Endofemoral Aimer tip may separate due to failure of the soldered joint | 734 units | 2012-05-09 |
| 2010-04-29 | Not classified | Component design/selection | Endofemoral Aimer tip may separate due to failure of the soldered joint | 754 units | 2012-05-09 |
| 2010-04-29 | Not classified | Component design/selection | Endofemoral Aimer tip may separate due to failure of the soldered joint | 10 units | 2012-05-09 |
| 2010-04-29 | Not classified | Component design/selection | Endofemoral Aimer tip may separate due to failure of the soldered joint | 811 units | 2012-05-09 |
| 2010-04-29 | Not classified | Component design/selection | Endofemoral Aimer tip may separate due to failure of the soldered joint | 7 units | 2012-05-09 |
| 2010-04-29 | Not classified | Component design/selection | Endofemoral Aimer tip may separate due to failure of the soldered joint | 5 units | 2012-05-09 |
| 2010-04-29 | Not classified | Component design/selection | Endofemoral Aimer tip may separate due to failure of the soldered joint | 704 units | 2012-05-09 |
| 2009-09-03 | Not classified | Labeling design | Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm. | 2012-05-08 | |
| 2009-09-03 | Not classified | Labeling design | Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm. | 2012-05-08 | |
| 2009-09-03 | Not classified | Labeling design | Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm. | 134 individual units | 2012-05-08 |
| 2009-05-07 | Not classified | Pending | Product sterility is compromised due to breach in the sterile packaging. | 168 units | 2012-05-08 |
| 2009-05-07 | Not classified | Pending | Product sterility is compromised due to breach in the sterile packaging. | 906 units | 2012-05-08 |
| 2009-05-07 | Not classified | Pending | Product sterility is compromised due to breach in the sterile packaging. | 174 units | 2012-05-08 |
| 2009-05-07 | Not classified | Pending | Product sterility is compromised due to breach in the sterile packaging. | 948 units | 2012-05-08 |
| 2009-05-07 | Not classified | Pending | Product sterility is compromised due to breach in the sterile packaging. | 4,206 units | 2012-05-08 |
| 2009-05-07 | Not classified | Pending | Product sterility is compromised due to breach in the sterile packaging. | 6,432 units | 2012-05-08 |
| 2009-05-07 | Not classified | Pending | Product sterility is compromised due to breach in the sterile packaging. | 342 units | 2012-05-08 |
| 2009-05-07 | Not classified | Pending | Product sterility is compromised due to breach in the sterile packaging. | 462 units | 2012-05-08 |
| 2006-11-01 | Not classified | Other | The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board. | 12 | 2008-06-16 |
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.