S-ROM
S-ROM Distal Stem Trial, XX-Long - Neutral Size 17
21manufacturers in China registered for this device type
74catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 21. All 21 manufacturers in China registered for Template
Record
| Listed by | Depuy Orthopaedics, Inc., United States |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2024-12-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2576-22-130 | In distribution | |
| 2576-17-112 | In distribution | |
| 2576-17-108 | In distribution | |
| 53-7032 | In distribution | |
| 2576-17-110 | In distribution | |
| 53-6304 | In distribution | |
| 2576-13-106 | In distribution | |
| 2531-70-500 | In distribution | |
| 2531-69-500 | In distribution | |
| 2576-11-106 | In distribution | |
| 87-5918 | In distribution | |
| 2576-24-130 | In distribution | |
| 2576-19-112 | In distribution | |
| 53-8026 | In distribution | |
| 2576-13-112 | In distribution | |
| 53-8014 | In distribution | |
| 2576-00-004 | In distribution | |
| 2576-36-008 | In distribution | |
| 2576-11-110 | In distribution | |
| 2531-80-500 | In distribution | |
| 2576-30-004 | In distribution | |
| 2576-21-110 | In distribution | |
| 2576-05-021 | In distribution | |
| 53-2732 | In distribution | |
| 53-7028 | In distribution | |
| 53-3328 | In distribution | |
| 2576-11-112 | In distribution | |
| 2576-36-221 | In distribution | |
| 2576-20-130 | In distribution | |
| 53-6346 | In distribution | |
| XRT115 | In distribution | |
| 2576-19-110 | In distribution | |
| 2576-16-130 | In distribution | |
| 2576-19-108 | In distribution | |
| 2576-05-029 | In distribution | |
| 2576-21-106 | In distribution | |
| 2576-13-108 | In distribution | |
| 53-6307 | In distribution | |
| 54-0240 | In distribution | |
| 53-8004 | In distribution | |
| 53-6303 | In distribution | |
| 2576-05-019 | In distribution | |
| 2576-05-017 | In distribution | |
| 2576-13-110 | In distribution | |
| 87-5919 | In distribution | |
| 2576-05-031 | In distribution | |
| 2576-05-023 | In distribution | |
| 53-8024 | In distribution | |
| 2576-21-112 | In distribution | |
| 2531-81-500 | In distribution | |
| 54-0260 | In distribution | |
| 53-6310 | In distribution | |
| 2576-18-130 | In distribution | |
| 2576-05-117 | In distribution | |
| 2576-36-021 | In distribution | |
| 53-8016 | In distribution | |
| 2576-36-012 | In distribution | |
| 54-0270 | In distribution | |
| 2576-36-006 | In distribution | |
| 53-6306 | In distribution | |
| 53-8002 | In distribution | |
| 53-6710 | In distribution | |
| 2576-11-108 | In distribution | |
| 2576-15-112 | In distribution | |
| XRT-142 | In distribution | |
| 2576-36-121 | In distribution | |
| 53-8012 | In distribution | |
| 2576-15-110 | In distribution | |
| 53-8022 | In distribution | |
| 2576-17-106 | In distribution | |
| 2576-19-106 | In distribution | |
| 2576-21-108 | In distribution | |
| 2531-79-500 | In distribution | |
| 2576-05-015 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Attune | Depuy (Ireland) | 1,385 |
| Template | Exactech, Inc. | 1,277 |
| 4WEB Medical | 4WEB Inc. | 991 |
| Evolution® | Microport Orthopedics Inc. | 966 |
| Template | Zimmer, Inc. | 792 |
| Advance® | Microport Orthopedics Inc. | 644 |
| Apex Knee System | Omni Life Science, Inc. | 635 |
| Profemur® | Microport Orthopedics Inc. | 591 |
| Link Instruments – Trial implants and size gauges | Waldemar Link GmbH & Co. KG | 549 |
| Template | Synthes Gmbh | 516 |
| Optetrak Logic | Exactech, Inc. | 512 |
| Template | Depuy Spine, Inc. | 451 |
Showing 12 of 2,940. All products under Template
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 |
|---|---|---|---|---|---|
| 2022-06-29 | Class II | Process control | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surg | 872 units | |
| 2014-03-28 | Class II | Device Design | Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patie | 21,675 | 2014-12-04 |
| 2013-05-03 | Class II | Process control | The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. Using the improperly | 20 units | 2013-08-28 |
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.