Mesh, Surgical, Acetabular, Hip, Prosthesis
30 catalogue numbers from 9362-28-053, listed by Zimmer, Inc., United States, under Mesh, Surgical, Acetabular, Hip, Prosthesis. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
30catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | JDJ |
| Device type | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K022985 |
| Record published | 2016-07-19 |
| Record revised | 2023-04-04 (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 |
| Distribution end date | 2017-05-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9362-28-053 | Size 28 mm/53 mm | In distribution |
| 9363-32-061 | Size 32mm/61mm | In distribution |
| 9363-22-045 | Size 22mm/45mm | In distribution |
| 9363-26-049 | Size 26mm/49mm | In distribution |
| 9666-22-800 | 12/14 Taper Trial Head, 22 mm, +8.0 mm Neck | In distribution |
| 9362-26-061 | Size 26 mm/61 mm | In distribution |
| 9666-44-400 | 12/14 Taper Trial Head, 44 mm, +4.0 mm Neck | In distribution |
| 9362-44-065 | Size 44mm/65mm | In distribution |
| 9362-38-073 | Size 38mm/73mm | In distribution |
| 9363-28-055 | Size 28mm/55mm | In distribution |
| 9363-28-053 | Size 28mm/53mm | In distribution |
| 9363-99-132 | 28 mm Hooded Insert Trials Tray | In distribution |
| 9666-44-800 | 12/14 Taper Trial Head, 44 mm, +8.0 mm Neck | In distribution |
| 9362-38-075 | Size 38mm/75mm | In distribution |
| 9364-32-055 | Size 32mm/55mm | In distribution |
| 9666-44-008 | 12/14 Taper Trial Head, 44 mm, -8.0 mm Neck | In distribution |
| 9362-28-063 | Size 28 mm/63 mm | In distribution |
| 9365-99-153 | In distribution | |
| 9362-26-049 | Size 26 mm/49 mm | In distribution |
| 9363-32-069 | Size 32mm/69mm | In distribution |
| 9364-28-059 | Size 28mm/59mm | In distribution |
| 9362-28-069 | Size 28 mm/69 mm | In distribution |
| 9364-28-051 | Size 28mm/51mm | In distribution |
| 9362-44-081 | Size 44mm/81mm | In distribution |
| 9364-99-142 | 32 mm Protrusio Insert Trials Tray | In distribution |
| 9362-22-043 | Size 22 mm/43 mm | In distribution |
| 9363-26-057 | Size 26mm/57mm | In distribution |
| 9360-00-068 | Size 68 mm | Withdrawn |
| 9360-00-064 | Size 64 mm | Withdrawn |
| 9360-00-050 | Size 50 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mesh, Surgical, Acetabular, Hip, Prosthesis | Depuy Orthopaedics, Inc. | 35 |
| Contour | Smith & Nephew, Inc. | 19 |
| Restoration | Howmedica Osteonics Corp | 5 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2023-02-27 | Class II | Under Investigation by firm | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in fl | 1,168 untits | |
| Zimmer, Inc. | 510(k) number | 2014-12-17 | Class II | Package design/selection | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic inf | 1908 | 2015-09-23 |
| Zimmer, Inc. | 510(k) number | 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 1000 | 2014-04-16 |
| Centerpulse Orthopedics, Inc. | 510(k) number | 2003-09-30 | Not classified | Other | Compalints of acetabular shell disassociating with the bone. | 145 units | 2004-11-04 |
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.