Sigma LCS High Performance
Sigma LCS High Performance MBT Keel Punch Noncemented Size 1-1.5
9manufacturers in China registered for this device type
6catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Guangdong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Record
| Listed by | Depuy Orthopaedics, Inc., United States |
|---|---|
| FDA product code | LRY |
| Device type | Punch, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2024-11-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2020-12-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9505-02-012 | Withdrawn | |
| 9505-02-011 | Withdrawn | |
| 9505-02-014 | Withdrawn | |
| 9505-02-013 | Withdrawn | |
| 9505-02-015 | Withdrawn | |
| 9505-02-010 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 693 |
| Ambler Surgical | Ambler Surgical, LLC | 317 |
| Orthomed | Ortho-MED, Inc. | 228 |
| Aesculap | Aesculap AG | 187 |
| Lazic | Peter Lazic Gmbh | 148 |
| Noir | Aesculap AG | 66 |
| MaxMoreSpine | Hoogland Spine Products GmbH | 44 |
| Kerrison | Elliquence LLC | 36 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 33 |
| Punch, Surgical | Doppkon Gmbh & Co. KG | 29 |
| Scharf | Scharf Tools Ihracat Ithalat Limited Sirketi | 29 |
| Henry Schein | Henry Schein, Inc. | 27 |
Showing 12 of 216. All products under Punch, Surgical
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 |
|---|---|---|---|---|---|
| 2016-01-08 | Class II | Component design/selection | Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to | 351 | 2017-03-24 |
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.