G-Force
11 catalogue numbers from 86PS0615, listed by Wright Medical Technology, Inc., United States, under Fastener, Fixation, Nondegradable, Soft Tissue. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
11catalogue numbers in this listing
12recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Renolit Hansen Packaging Tech. (BJ) Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K100630 |
| Record published | 2015-10-01 |
| Record revised | 2022-04-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 3.5 to 8 mm; length 10 to 25 mm |
| Distribution end date | 2016-03-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 86PS0615 | Length 15 mm | In distribution |
| 86PS0410 | Length 10 mm | In distribution |
| 86PS0415 | Length 15 mm | In distribution |
| 86PS0725 | Length 25 mm | In distribution |
| 86TA50N2 | Outer Diameter 5.0 mm | In distribution |
| 86PS0510 | Outer Diameter 5 mm | In distribution |
| 86PS0620 | Outer Diameter 6 mm | In distribution |
| 86PS0825 | Outer Diameter 8 mm | In distribution |
| 86PS0515 | Length 15 mm | In distribution |
| 86PA50N2 | Suture: 4 | Withdrawn |
| 86TA35N0 | Suture: 0 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 362 |
| HNM Sports Medicine | HNM Stainless, LLC. | 150 |
| Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors | GM DOS Reis Industria E Comercio Ltda | 78 |
| Juggerknot® | Biomet Orthopedics | 77 |
| Fastener, Fixation, Nondegradable, Soft Tissue | Parcus Medical, LLC | 74 |
| endophix | Suzhou Endophix Co., Ltd. | 71 |
| Titan | Medline Industries, Inc. | 68 |
| TopLock | Fusion Orthopedics, LLC | 67 |
| HNM Medical | HNM Stainless, LLC. | 59 |
| Orthobutton CL | Riverpoint Medical LLC | 55 |
| Apollo | Medline Industries, Inc. | 53 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
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 |
|---|---|---|---|---|---|
| 2011-09-20 | Not classified | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. | 325 units | 2012-07-17 |
| 2011-09-20 | Not classified | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. | 1237 units | 2012-07-17 |
| 2011-09-20 | Not classified | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. | 4472 units | 2012-07-17 |
| 2011-09-20 | Not classified | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. | 1228 units | 2012-07-17 |
| 2011-09-20 | Not classified | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. | 2239 units | 2012-07-17 |
| 2011-09-20 | Not classified | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. | 596 units | 2012-07-17 |
| 2011-09-20 | Not classified | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. | 59 units | 2012-07-17 |
| 2011-09-20 | Not classified | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. | 1099 units | 2012-07-17 |
| 2011-09-20 | Not classified | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. | 91 units | 2012-07-17 |
| 2011-09-20 | Not classified | Incorrect or no expiration date | The product is labeled with an expiration date without adequate justification. | 614 units | 2012-07-17 |
| 2011-01-11 | Not classified | Other | Driver may break during use. | 10 units | 2011-07-11 |
| 2011-01-11 | Not classified | Other | Driver may break during use. | 45 units | 2011-07-11 |
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.