Zimmer® DTO®
Zimmer® DTO® Pin press
4manufacturers in China registered for this device type
15catalogue numbers in this listing
7recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (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 |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | NQP |
| Device type | Posterior Metal/Polymer Spinal System, Fusion |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K101704 |
| Record published | 2016-08-29 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 40 to 100 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 01.03799.058 | In distribution | ||
| 01.03791.080 | Length 80 mm | 2 | In distribution |
| 01.03791.050 | Length 50 mm | 2 | In distribution |
| 01.03791.090 | Length 90 mm | 2 | In distribution |
| 01.03791.050 | Length 50 mm | 2 | In distribution |
| 01.03791.060 | Length 60 mm | 2 | In distribution |
| 01.03791.080 | Length 80 mm | 2 | In distribution |
| 01.03791.070 | Length 70 mm | 2 | In distribution |
| 01.03791.060 | Length 60 mm | 2 | In distribution |
| 01.03791.100 | Length 100 mm | 2 | In distribution |
| 01.03791.100 | Length 100 mm | 2 | In distribution |
| 01.03791.040 | Length 40 mm | 2 | In distribution |
| 01.03791.090 | Length 90 mm | 2 | In distribution |
| 01.03791.070 | Length 70 mm | 2 | In distribution |
| 01.03791.040 | Length 40 mm | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 311 |
| Transition | Globus Medical, Inc. | 278 |
| Dynesys® | Zimmer, Inc. | 139 |
| Dynesys® Top-Loading System | Zimmer, Inc. | 103 |
| Dynesys® | Zimmer Spine, Inc. | 29 |
| CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek, Inc. | 9 |
| Dynesys Dynamic Stabilization System | Highridge Medical, LLC | 5 |
| DSS Pedicle screw set, Ø5.0 x 30mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø5.0 x 40mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø7.0 x 45mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø5.0 x 50mm | Paradigm Spine GmbH | 2 |
| DSS Pedicle screw set, Ø8.0 x 50mm | Paradigm Spine GmbH | 2 |
Showing 12 of 83. All products under Posterior Metal/Polymer Spinal System, Fusion
Recalls
6 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 |
|---|---|---|---|---|---|
| 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 | 1575 | 2014-04-16 |
| 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 Winterthru, Switzerland, after receiving four complaints of a discrepancy between product patient | 1247 | 2014-04-16 |
| 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 | 2014-04-16 | |
| 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 | 1406 | 2014-04-16 |
| 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 | 5069 | 2014-04-16 |
| 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 | 58 | 2014-04-16 |
| 2009-05-28 | Not classified | Other | The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay. | 177 | 2011-10-05 |
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.