EXp Acetabular Shell and Liner
36 MM EXp Non-Hooded Liner
8manufacturers in China registered for this device type
24catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Shenzhen Fox Hunting E-commerce Co., Ltd. | Shenzhen | Guangdong | Exporter | 7 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | OQG |
| Device type | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-05-20 |
| Record revised | 2020-12-11 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC3260-36-7076 | In distribution | |
| SC3344-32-5456 | In distribution | |
| SC3260-36-5456 | In distribution | |
| SC3260-36-6264 | In distribution | |
| SC3349-36-7076 | In distribution | |
| SC3345-32-5052 | In distribution | |
| SC3345-32-6668 | In distribution | |
| SC3344-32-6668 | In distribution | |
| SC3344-32-5860 | In distribution | |
| SC3344-32-5052 | In distribution | |
| SC3345-32-5456 | In distribution | |
| SC3260-36-6668 | In distribution | |
| SC3349-36-5456 | In distribution | |
| SC3349-36-6668 | In distribution | |
| SC3345-32-5860 | In distribution | |
| SC3342-28-4648 | In distribution | |
| SC3342-28-5052 | In distribution | |
| SC3260-36-5860 | In distribution | |
| SC3349-36-6264 | In distribution | |
| SC3343-28-4648 | In distribution | |
| SC3344-32-6264 | In distribution | |
| SC3345-32-6264 | In distribution | |
| SC3343-28-5052 | In distribution | |
| SC3349-36-5860 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CS2 Acet. Cup Sys. – VitalitE | Shalby Advanced Technologies, Inc. | 169 |
| iTotal® Hip Replacement System | ConforMIS, Inc. | 131 |
| CS2 Acet. Cup Sys. – VitalitE | Consensus Orthopedics, Inc. | 124 |
| DJO Surgical | Encore Medical, L.P. | 99 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 68 |
| G7 | Biomet Orthopedics | 54 |
| Vitelene® | Aesculap AG | 52 |
| Conformis Hip System | ConforMIS, Inc. | 51 |
| Onvoy | Globus Medical, Inc. | 48 |
| Ringloc HIP System | Biomet Orthopedics | 35 |
| Novosource Total Hip System | Novosource, LLC | 33 |
| Prime | Microport Orthopedics Inc. | 32 |
Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2013-01-24 | Class II | Device Design | Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell. | 254 | 2014-10-08 |
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.