Proximity
Proximity is an anterior cervical plate system intended for anterior screw fixation to the cervical spine from C2 to T1. The filing describes the larger Alphatec Plating Systems submission…
Proximity is an anterior cervical plate system intended for anterior screw fixation to the cervical spine from C2 to T1.
The filing describes the larger Alphatec Plating Systems submission as including the Proximity system and a separate Segmental Plating System.
Listed Item
PROXIMITY VA SELF-DRILL SCREW, 4.0 x 23mm
Implant System Scope
The systems include plates and screws made from titanium alloy, with instruments for delivering the plate-and-screw constructs. The listed indications also include trauma, tumors, deformity, failed prior fusion and spinal stenosis.
14manufacturers in China registered for this device type
400catalogue numbers in this listing
9510(k) clearances naming this product code
32recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K251965 |
| Record published | 2025-12-19 |
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 10 to 110 mm; outer diameter 3.5 to 4 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 385-0488 | Length 88 mm | In distribution |
| 385-1-24023 | Length 23 mm | In distribution |
| 385-1-44024 | Outer Diameter 4 mm | In distribution |
| 385-0464-L-S | Length 64 mm | In distribution |
| 385-1-23512 | Length 12 mm | In distribution |
| 385-5090 | Length 90 mm | In distribution |
| 385-1-13524 | Outer Diameter 3.5 mm | In distribution |
| 385-0115-S | Length 15 mm | In distribution |
| 385-0460-L | Length 60 mm | In distribution |
| 385-1-33523 | Outer Diameter 3.5 mm | In distribution |
| 385-0248-L-S | Length 48 mm | In distribution |
| 385-0476-L | Length 76 mm | In distribution |
| 385-0117-L-S | Length 17 mm | In distribution |
| 385-0242-L | Length 42 mm | In distribution |
| 385-0230-L | Length 30 mm | In distribution |
| 385-1-23521 | Length 21 mm | In distribution |
| 385-0122 | Length 22 mm | In distribution |
| 385-0130 | Length 30 mm | In distribution |
| 385-0343-L | Length 43 mm | In distribution |
| 385-0355-S | Length 55 mm | In distribution |
| 385-0240-L-S | Length 40 mm | In distribution |
| 385-0344-S | Length 44 mm | In distribution |
| 385-0230-L-S | Length 30 mm | In distribution |
| 385-0486-L | Length 86 mm | In distribution |
| 385-0343-S | Length 43 mm | In distribution |
| 385-0370-L-S | Length 70 mm | In distribution |
| 385-1-24017 | Outer Diameter 4 mm | In distribution |
| 385-0119-S | Length 19 mm | In distribution |
| 385-0116-S | Length 16 mm | In distribution |
| 385-0240 | Length 40 mm | In distribution |
| 385-0236 | Length 36 mm | In distribution |
| 385-0126-S | Length 26 mm | In distribution |
| 385-0478 | Length 78 mm | In distribution |
| 385-0346-L-S | Length 46 mm | In distribution |
| 385-1-34011 | Length 11 mm | In distribution |
| 385-0361-L | Length 61 mm | In distribution |
| 385-0234-L-S | Length 34 mm | In distribution |
| 385-1-34018 | Outer Diameter 4 mm | In distribution |
| 385-0356-L | Length 56 mm | In distribution |
| 385-0128-L | Length 28 mm | In distribution |
| 385-0486 | Length 86 mm | In distribution |
| 385-0466 | Length 66 mm | In distribution |
| 385-0134-L | Length 34 mm | In distribution |
| 385-0366-S | Length 66 mm | In distribution |
| 385-0246 | Length 46 mm | In distribution |
| 385-0117-S | Length 17 mm | In distribution |
| 385-0342-L-S | Length 42 mm | In distribution |
| 385-1-43519 | Length 19 mm | In distribution |
| 385-5100 | Length 100 mm | In distribution |
| 385-0250-L-S | Length 50 mm | In distribution |
| 385-0468-L-S | Length 68 mm | In distribution |
| 385-0242-S | Length 42 mm | In distribution |
| 385-1-14017 | Length 17 mm | In distribution |
| 385-0466-L | Length 66 mm | In distribution |
| 385-0234-L | Length 34 mm | In distribution |
| 385-1-24011 | Length 11 mm | In distribution |
| 385-5105-L | Length 105 mm | In distribution |
| 385-0340-L | Length 40 mm | In distribution |
| 385-5090-S | Length 90 mm | In distribution |
| 385-1-34014 | Length 14 mm | In distribution |
| 385-0352 | Length 52 mm | In distribution |
| 385-0470-S | Length 70 mm | In distribution |
| 385-0124-L | Length 24 mm | In distribution |
| 385-0354-L | Length 54 mm | In distribution |
| 385-1-14012 | Length 12 mm | In distribution |
| 385-0117 | Length 17 mm | In distribution |
| 385-0242 | Length 42 mm | In distribution |
| 385-0348-L | Length 48 mm | In distribution |
| 385-5105-S | Length 105 mm | In distribution |
| 385-0464-S | Length 64 mm | In distribution |
| 385-0126 | Length 26 mm | In distribution |
| 385-0368-L-S | Length 68 mm | In distribution |
| 385-0361-S | Length 61 mm | In distribution |
| 385-0480 | Length 80 mm | In distribution |
| 385-1-14024 | Length 24 mm | In distribution |
| 385-0480-L | Length 80 mm | In distribution |
| 385-0238-L | Length 38 mm | In distribution |
| 385-0130-L | Length 30 mm | In distribution |
| 385-1-43515 | Outer Diameter 3.5 mm | In distribution |
| 385-5100-S | Length 100 mm | In distribution |
| 385-0470 | Length 70 mm | In distribution |
| 385-0464-L | Length 64 mm | In distribution |
| 385-0348-S | Length 48 mm | In distribution |
| 385-0246-S | Length 46 mm | In distribution |
| 385-0462 | Length 62 mm | In distribution |
| 385-1-13513 | Length 13 mm | In distribution |
| 385-0119 | Length 19 mm | In distribution |
| 385-0118 | Length 18 mm | In distribution |
| 385-0132-L | Length 32 mm | In distribution |
| 385-0368-L | Length 68 mm | In distribution |
| 385-1-33518 | Length 18 mm | In distribution |
| 385-0230 | Length 30 mm | In distribution |
| 385-1-33511 | Outer Diameter 3.5 mm | In distribution |
| 385-0123 | Length 23 mm | In distribution |
| 385-0340 | Length 40 mm | In distribution |
| 385-5105-L-S | Length 105 mm | In distribution |
| 385-1-14019 | Length 19 mm | In distribution |
| 385-1-13514 | Outer Diameter 3.5 mm | In distribution |
| 385-0115-L-S | Length 15 mm | In distribution |
| 385-0254-S | Length 54 mm | In distribution |
| 385-0482-S | Length 82 mm | In distribution |
| 385-1-24022 | Length 22 mm | In distribution |
| 385-0472-L-S | Length 72 mm | In distribution |
| 385-1-44017 | Length 17 mm | In distribution |
| 385-0342-L | Length 42 mm | In distribution |
| 385-1-24016 | Outer Diameter 4 mm | In distribution |
| 385-0464 | Length 64 mm | In distribution |
| 385-0121-L-S | Length 21 mm | In distribution |
| 385-1-43510 | Length 10 mm | In distribution |
| 385-0126-L-S | Length 26 mm | In distribution |
| 385-0476-S | Length 76 mm | In distribution |
| 385-1-14015 | Length 15 mm | In distribution |
| 385-0254 | Length 54 mm | In distribution |
| 385-0488-S | Length 88 mm | In distribution |
| 385-1-24021 | Outer Diameter 4 mm | In distribution |
| 385-1-23510 | Length 10 mm | In distribution |
| 385-0254-L | Length 54 mm | In distribution |
| 385-0476 | Length 76 mm | In distribution |
| 385-0349-L-S | Length 49 mm | In distribution |
| 385-0484-L | Length 84 mm | In distribution |
| 385-1-44011 | Length 11 mm | In distribution |
| 385-0476-L-S | Length 76 mm | In distribution |
| 385-0236-L | Length 36 mm | In distribution |
| 385-0232-L-S | Length 32 mm | In distribution |
| 385-1-33517 | Length 17 mm | In distribution |
| 385-0124-S | Length 24 mm | In distribution |
| 385-0370 | Length 70 mm | In distribution |
| 385-0355 | Length 55 mm | In distribution |
| 385-0354-S | Length 54 mm | In distribution |
| 385-0123-L | Length 23 mm | In distribution |
| 385-0238 | Length 38 mm | In distribution |
| 385-0367 | Length 67 mm | In distribution |
| 385-1-23515 | Length 15 mm | In distribution |
| 385-0230-S | Length 30 mm | In distribution |
| 385-0460 | Length 60 mm | In distribution |
| 385-0370-L | Length 70 mm | In distribution |
| 385-0370-S | Length 70 mm | In distribution |
| 385-1-13510 | Length 10 mm | In distribution |
| 385-0252-L | Length 52 mm | In distribution |
| 385-0252 | Length 52 mm | In distribution |
| 385-0486-S | Length 86 mm | In distribution |
| 385-0340-S | Length 40 mm | In distribution |
| 385-0120 | Length 20 mm | In distribution |
| 385-0119-L-S | Length 19 mm | In distribution |
| 385-0468 | Length 68 mm | In distribution |
| 385-0244-S | Length 44 mm | In distribution |
| 385-0366-L-S | Length 66 mm | In distribution |
| 385-0244-L-S | Length 44 mm | In distribution |
| 385-0474-L-S | Length 74 mm | In distribution |
| 385-0460-S | Length 60 mm | In distribution |
| 385-0349 | Length 49 mm | In distribution |
| 385-0490 | Length 90 mm | In distribution |
| 385-1-24018 | Outer Diameter 4 mm | In distribution |
| 385-0120-L | Length 20 mm | In distribution |
| 385-0352-L | Length 52 mm | In distribution |
| 385-1-24015 | Length 15 mm | In distribution |
| 385-1-24012 | Outer Diameter 4 mm | In distribution |
| 385-0358-S | Length 58 mm | In distribution |
| 385-1-14021 | Length 21 mm | In distribution |
| 385-1-43523 | Length 23 mm | In distribution |
| 385-0362-L | Length 62 mm | In distribution |
| 385-0118-L | Length 18 mm | In distribution |
| 385-0348-L-S | Length 48 mm | In distribution |
| 385-1-23513 | Length 13 mm | In distribution |
| 385-0480-S | Length 80 mm | In distribution |
| 385-0343-L-S | Length 43 mm | In distribution |
| 385-0124 | Length 24 mm | In distribution |
| 385-1-23524 | Outer Diameter 3.5 mm | In distribution |
| 385-0358 | Length 58 mm | In distribution |
| 385-1-14010 | Length 10 mm | In distribution |
| 385-1-33514 | Length 14 mm | In distribution |
| 385-0115 | Length 15 mm | In distribution |
| 385-5100-L-S | Length 100 mm | In distribution |
| 385-1-43516 | Length 16 mm | In distribution |
| 385-0360-S | Length 60 mm | In distribution |
| 385-0350-L-S | Length 50 mm | In distribution |
| 385-1-24020 | Outer Diameter 4 mm | In distribution |
| 385-0240-L | Length 40 mm | In distribution |
| 385-0364-L-S | Length 64 mm | In distribution |
| 385-1-14016 | Outer Diameter 4 mm | In distribution |
| 385-1-44014 | Length 14 mm | In distribution |
| 385-0466-S | Length 66 mm | In distribution |
| 385-1-24013 | Length 13 mm | In distribution |
| 385-0238-S | Length 38 mm | In distribution |
| 385-1-44013 | Length 13 mm | In distribution |
| 385-0364-S | Length 64 mm | In distribution |
| 385-1-13520 | Outer Diameter 3.5 mm | In distribution |
| 385-0132-S | Length 32 mm | In distribution |
| 385-1-33520 | Length 20 mm | In distribution |
| 385-1-14023 | Outer Diameter 4 mm | In distribution |
| 385-1-34015 | Outer Diameter 4 mm | In distribution |
| 385-0472-L | Length 72 mm | In distribution |
| 385-1-14013 | Outer Diameter 4 mm | In distribution |
| 385-5090-L-S | Length 90 mm | In distribution |
| 385-5100-L | Length 100 mm | In distribution |
| 385-1-44018 | Outer Diameter 4 mm | In distribution |
| 385-0366-L | Length 66 mm | In distribution |
| 385-0349-S | Length 49 mm | In distribution |
| 385-1-34021 | Outer Diameter 4 mm | In distribution |
| 385-1-34013 | Outer Diameter 4 mm | In distribution |
| 385-1-34012 | Outer Diameter 4 mm | In distribution |
| 385-0484-S | Length 84 mm | In distribution |
| 385-1-13522 | Length 22 mm | In distribution |
| 385-1-24024 | Length 24 mm | In distribution |
| 385-5110-L-S | Length 110 mm | In distribution |
| 385-0254-L-S | Length 54 mm | In distribution |
| 385-0244 | Length 44 mm | In distribution |
| 385-0244-L | Length 44 mm | In distribution |
| 385-0367-L | Length 67 mm | In distribution |
| 385-1-23518 | Length 18 mm | In distribution |
| 385-1-14022 | Length 22 mm | In distribution |
| 385-0352-L-S | Length 52 mm | In distribution |
| 385-0478-S | Length 78 mm | In distribution |
| 385-1-43512 | Outer Diameter 3.5 mm | In distribution |
| 385-0354-L-S | Length 54 mm | In distribution |
| 385-5090-L | Length 90 mm | In distribution |
| 385-0354 | Length 54 mm | In distribution |
| 385-0350 | Length 50 mm | In distribution |
| 385-1-43522 | Outer Diameter 3.5 mm | In distribution |
| 385-0132 | Length 32 mm | In distribution |
| 385-5110-L | Length 110 mm | In distribution |
| 385-1-23511 | Length 11 mm | In distribution |
| 385-0360-L-S | Length 60 mm | In distribution |
| 385-1-34024 | Outer Diameter 4 mm | In distribution |
| 385-1-13511 | Outer Diameter 3.5 mm | In distribution |
| 385-0349-L | Length 49 mm | In distribution |
| 385-0360-L | Length 60 mm | In distribution |
| 385-0132-L-S | Length 32 mm | In distribution |
| 385-0346-L | Length 46 mm | In distribution |
| 385-0466-L-S | Length 66 mm | In distribution |
| 385-0240-S | Length 40 mm | In distribution |
| 385-5095-S | Length 95 mm | In distribution |
| 385-0252-L-S | Length 52 mm | In distribution |
| 385-0340-L-S | Length 40 mm | In distribution |
| 385-1-24014 | Outer Diameter 4 mm | In distribution |
| 385-0490-L-S | Length 90 mm | In distribution |
| 385-5110-S | Length 110 mm | In distribution |
| 385-1-44012 | Outer Diameter 4 mm | In distribution |
| 385-0121-L | Length 21 mm | In distribution |
| 385-0119-L | Length 19 mm | In distribution |
| 385-1-43517 | Outer Diameter 3.5 mm | In distribution |
| 385-0342-S | Length 42 mm | In distribution |
| 385-0356-S | Length 56 mm | In distribution |
| 385-1-14018 | Outer Diameter 4 mm | In distribution |
| 385-0350-L | Length 50 mm | In distribution |
| 385-1-33513 | Length 13 mm | In distribution |
| 385-1-44010 | Length 10 mm | In distribution |
| 385-0232-S | Length 32 mm | In distribution |
| 385-1-44016 | Length 16 mm | In distribution |
| 385-0480-L-S | Length 80 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251965 | 2025-08-28 |
| K233640 | 2024-02-22 |
| K230721 | 2023-05-09 |
| K213443 | 2021-12-15 |
| K200995 | 2020-05-21 |
| K182808 | 2018-11-09 |
| K102820 | 2010-11-05 |
| K101255 | 2010-07-21 |
| K070681 | 2007-05-04 |
Recalls
31 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 |
|---|---|---|---|---|---|
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 10 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 2 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 8 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 8 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 unit | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 5 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 6 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 unit | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 8 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 6 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 18 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 19 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 5 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 14 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 4 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 26 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 unit | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 2022-11-17 | |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 13 units | 2022-11-17 |
| 2015-04-10 | Class II | Employee error | During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recal | (244 units in US and 61 units OUS) | 2015-07-10 |
| 2012-05-29 | Class II | Device Design | On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate. | 38 | 2012-09-04 |
| 2009-08-25 | Not classified | Labeling mix-ups | The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical | 13 units | 2010-06-07 |
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.