R3
R3 20 Degree +4 Xlpe Acetabular Acetabular Liner 44 Inner Diameter X 76-80 Outer Diameter
5manufacturers in China registered for this device type
177catalogue numbers in this listing
9510(k) clearances naming this product code
9recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | MBL |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K182535 |
| Record published | 2018-12-02 |
| Record revised | 2025-08-04 (version 9) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: : – |
| Sizes | Angle 20 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71332408 | In distribution | |
| 71332404 | In distribution | |
| 71338699 | In distribution | |
| 71332438 | In distribution | |
| 71332471 | In distribution | |
| 71338686 | In distribution | |
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| 71332483 | In distribution | |
| 71332412 | In distribution | |
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| 71332494 | In distribution | |
| 71338695 | In distribution | |
| 71332414 | In distribution | |
| 71332418 | In distribution | |
| 71332374 | In distribution | |
| 71338687 | Angle 20 ° | In distribution |
| 71331124 | In distribution | |
| 71338704 | In distribution | |
| 71332666 | In distribution | |
| 71338711 | In distribution | |
| 71332474 | In distribution | |
| 71338682 | In distribution | |
| 71332440 | In distribution | |
| 71332496 | In distribution | |
| 71331102 | In distribution | |
| 71332375 | In distribution | |
| 71331098 | In distribution | |
| 71338680 | In distribution | |
| 71332376 | In distribution | |
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| 71331099 | In distribution | |
| 71332403 | In distribution | |
| 71338661 | In distribution | |
| 71934409 | In distribution | |
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| 71332424 | In distribution | |
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| 71330018 | In distribution | |
| 71338698 | In distribution | |
| 71331094 | In distribution | |
| 71332378 | In distribution | |
| 71331113 | In distribution | |
| 71332381 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument | Howmedica Osteonics Corp | 100 |
| Reflection | Smith & Nephew, Inc. | 89 |
| Profemur® | Microport Orthopedics Inc. | 53 |
| Delta | Limacorporate | 44 |
| Onvoy | Globus Medical, Inc. | 40 |
| Restoration | Howmedica Osteonics Corp | 39 |
| Dynasty | Microport Orthopedics Inc. | 28 |
| Delta Liners & Accessories | Limacorporate | 27 |
| R3, Stiktite | Smith & Nephew, Inc. | 26 |
| Biolox Delta | Limacorporate | 19 |
| Tri-plus | Ortho Development Corp. | 16 |
| Trident | Howmedica Osteonics Corp | 15 |
Showing 12 of 96. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201701 | 2020-10-06 |
| K182535 | 2018-11-19 |
| K161233 | 2016-12-14 |
| K113848 | 2012-04-27 |
| K102370 | 2011-01-19 |
| K093363 | 2010-01-26 |
| K092386 | 2009-11-03 |
| K070756 | 2007-06-06 |
| K061253 | 2006-05-31 |
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 1267 devices |
| Smith & Nephew, Inc. | 510(k) number | 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 1450 devices |
| Smith & Nephew, Inc. | 510(k) number | 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 6468 devices |
| Smith & Nephew, Inc. | 510(k) number | 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 4172 devices |
| Smith & Nephew, Inc. | 510(k) number | 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 1766 devices |
| Smith & Nephew, Inc. | 510(k) number | 2020-04-22 | Class II | Process control | A manufacturing error resulted in out of specification R3 Acetabular Shells | 58 devices |
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 |
|---|---|---|---|---|---|
| 2014-01-23 | Class II | Under Investigation by firm | Inner spherical radius of the shell is undersized. | 10 units | 2016-11-15 |
| 2013-05-29 | Class II | Packaging process control | One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner. | 53 units | 2016-03-22 |
| 2013-05-29 | Class II | Packaging process control | One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner. | 53 units | 2016-03-22 |
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.