Spline Implant System
63 catalogue numbers from 1561, listed by ZimVie US Corp LLC, United States, under Implant, Endosseous, Root-Form. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
63catalogue numbers in this listing
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | ZimVie US Corp LLC, United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K944327 |
| Record published | 2015-10-23 |
| Record revised | 2026-01-15 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-06-20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1561 | Ø3.25mm, Ø4.5mm x 1mm | In distribution | |
| 1621 | 2 | In distribution | |
| 1507 | Ø3.25mm, Ø4.5mm x 1mm | In distribution | |
| 1576 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 5mm | In distribution | |
| 1510 | Ø3.25mm, Ø4.5mm x 4mm | In distribution | |
| 1565 | Ø3.25mm, Ø4.5mm x 5mm | In distribution | |
| 1609 | In distribution | ||
| 1524 | Ø3.75mm & Ø4.0mm, Ø5.5mm x 0.5mm | In distribution | |
| 1500 | Ø3.25mm, Ø3.25mm | In distribution | |
| 1999 | In distribution | ||
| 1519 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 1mm | In distribution | |
| 1508 | Ø3.25mm, Ø4.5mm x 2mm | In distribution | |
| 2177 | Ø3.25mm, Ø4.5mm | In distribution | |
| 2174 | Ø3.75mm & Ø4.0mm, Ø4.5mm | 5 | In distribution |
| 1645 | 10mm, Ø4.5mm | 2 | In distribution |
| 1736 | In distribution | ||
| 1528 | Ø3.75mm & Ø4.0mm, Ø5.5mm x 4mm | In distribution | |
| 1734 | Ø5.0mm, Ø6.5mm x 1mm | In distribution | |
| 1732 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 1mm | In distribution | |
| 1671 | Ø3.25mm, Ø4.5mm x 0.5mm | In distribution | |
| 1520 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 2mm | In distribution | |
| 1525 | Ø3.75mm & Ø4.0mm, Ø5.5mm x 1mm | In distribution | |
| 2178 | Ø3.75mm & Ø4.0mm, Ø4.5mm | In distribution | |
| 1661 | Ø3.75mm & Ø4.0mm | 2 | In distribution |
| 1563 | Ø3.25mm, Ø4.5mm x 3mm | In distribution | |
| 1833 | In distribution | ||
| 1572 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 1mm | In distribution | |
| 1518 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 0.5mm | In distribution | |
| 1663 | Ø3.75mm & Ø4.0mm | In distribution | |
| 1731 | Ø3.25mm, Ø4.5mm x 3mm | In distribution | |
| 1522 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 4mm | In distribution | |
| 1686 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 1mm | In distribution | |
| 1506 | Ø3.25mm, Ø4.5mm x 0.5mm | In distribution | |
| 1677 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 0.5mm | In distribution | |
| 1573 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 2mm | In distribution | |
| 1998 | In distribution | ||
| 1505 | Ø5.0mm, Ø6.5mm x 4mm | In distribution | |
| 1526 | Ø3.75mm & Ø4.0mm, Ø5.5mm x 2mm | In distribution | |
| 1826 | In distribution | ||
| 1521 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 3mm | In distribution | |
| 1612 | In distribution | ||
| 1562 | Ø3.25mm, Ø4.5mm x 2mm | In distribution | |
| 1541 | In distribution | ||
| 1537 | In distribution | ||
| 1733 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 3mm | In distribution | |
| 1917 | 4mm, Ø6.5mm | In distribution | |
| 1735 | Ø5.0mm, Ø6.5mm x 3mm | In distribution | |
| 1501 | Ø3.75mm & Ø4.0mm, Ø4.0mm | In distribution | |
| 1564 | Ø3.25mm, Ø4.5mm x 4mm | In distribution | |
| 1915 | 4mm, Ø4.5mm | In distribution | |
| 1574 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 3mm | In distribution | |
| 2000 | In distribution | ||
| 1575 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 4mm | In distribution | |
| 1509 | Ø3.25mm, Ø4.5mm x 3mm | In distribution | |
| 1640 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 2mm | Withdrawn | |
| 1418 | Withdrawn | ||
| 1641 | Ø3.75mm & Ø4.0mm, Ø4.5mm x 3mm | Withdrawn | |
| 1636 | Ø3.25mm, Ø4.5mm x 2mm | Withdrawn | |
| 1643 | Withdrawn | ||
| 1639 | Ø3.25mm, Ø4.5mm x 5mm | Withdrawn | |
| 1637 | Ø3.25mm, Ø4.5mm x 3mm | Withdrawn | |
| 1642 | Withdrawn | ||
| 1638 | Ø3.25mm, Ø4.5mm x 4mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
Recalls
40 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 |
|---|---|---|---|---|---|
| 2018-05-10 | Class II | Labeling mix-ups | Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling. | 299 units | 2020-08-19 |
| 2017-11-29 | Class II | Packaging process control | Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled. | 995 distribution events total | 2019-02-08 |
| 2017-11-29 | Class II | Packaging process control | Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled. | 995 distribution events total | 2019-02-08 |
| 2017-11-20 | Class II | Under Investigation by firm | Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition. | 500 units | 2024-02-28 |
| 2017-07-10 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs. | 13,235 products | 2019-08-05 |
| 2017-07-10 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs. | 169 products | 2019-08-05 |
| 2017-03-20 | Class II | Nonconforming Material/Component | It was manufactured with the minor diameter of the internal thread that is below specification. | 188 units | 2017-11-01 |
| 2017-03-08 | Class II | Under Investigation by firm | A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier | 5 | 2019-08-02 |
| 2016-08-08 | Class II | Packaging process control | Product was incorrectly packaged. | 92 units | 2019-08-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1050 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1050 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2016-01-06 | Class II | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. | 1059 | 2016-05-06 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 devices (all products subject to this recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 devices (all products subject to this recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 (all products subject to these recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 (all products subject to these recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 (all products subject to thIs recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 (all products subject to these recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1, 648,273 devices (all products subject to this recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 devices (all products subject to this recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 devices (all products subject to this recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 devices (all products subject to this recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 (all products subject to these recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 (all products subject to these recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 (all products subject to these recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 devices (all products subject to this recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 devices (all products subject to this recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1, 648,273 devices (all products subject to this recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 devices (all products subject to this recall) | 2019-07-26 |
| 2015-11-25 | Class II | Packaging | Pouches may not have been sealed during packing. | 1,648,273 devices (all products subject to this recall) | 2019-07-26 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
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.