Ortholoc
LOW PRO Cort Screw 2.7X18MM Ortholoc™ System
22manufacturers in China registered for this device type
222catalogue numbers in this listing
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K091243 |
| Record published | 2015-10-01 |
| Record revised | 2025-02-06 (version 8) |
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 8 to 60 mm; outer diameter 2 to 4 mm |
| Distribution end date | 2016-03-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 58813550 | Length 50 mm | In distribution |
| 535S035060 | Length 60 mm | In distribution |
| 58S23540 | Outer Diameter 3.5 mm | In distribution |
| 58812716 | Outer Diameter 2.7 mm | In distribution |
| 5351035022 | Length 22 mm | In distribution |
| 5351035040 | Outer Diameter 3.5 mm | In distribution |
| 5351035050 | Outer Diameter 3.5 mm | In distribution |
| 58S23538 | Length 38 mm | In distribution |
| 58813518 | Length 18 mm | In distribution |
| 59240000 | Size: 4.5/5.5 | In distribution |
| 58S12716 | Outer Diameter 2.7 mm | In distribution |
| 535S135026 | Non-Locking | In distribution |
| 520S020020 | Outer Diameter 2 mm | In distribution |
| 58S44030 | Length 30 mm | In distribution |
| 520S024024 | Length 24 mm | In distribution |
| 58S23522 | Length 22 mm | In distribution |
| 520S024020 | Length 20 mm | In distribution |
| 58S34028 | Length 28 mm | In distribution |
| 58S24018 | Length 18 mm | In distribution |
| 5201124012 | Outer Diameter 2.4 mm | In distribution |
| 58S23548 | Length 48 mm | In distribution |
| 58934024 | Length 24 mm | In distribution |
| 535S035024 | Length 24 mm | In distribution |
| 535S135030 | Outer Diameter 3.5 mm | In distribution |
| 5351135044 | Length 44 mm | In distribution |
| 58813546 | Outer Diameter 3.5 mm | In distribution |
| 58812728 | Outer Diameter 2.7 mm | In distribution |
| 520S000306 | Straight | In distribution |
| 58S24022 | Length 22 mm | In distribution |
| 58S13512 | Length 12 mm | In distribution |
| 58S24060 | Length 60 mm | In distribution |
| 58S24026 | Outer Diameter 4 mm | In distribution |
| 58S44050 | Length 50 mm | In distribution |
| 58S23555 | Outer Diameter 3.5 mm | In distribution |
| 58944055 | Outer Diameter 4 mm | In distribution |
| 58813540 | Outer Diameter 3.5 mm | In distribution |
| 58S34050 | Outer Diameter 4 mm | In distribution |
| 58944030 | Length 30 mm | In distribution |
| 5201020010 | Outer Diameter 2 mm | In distribution |
| 5361006001 | Size: Small | In distribution |
| 58S44035 | Outer Diameter 4 mm | In distribution |
| 58913530 | Length 30 mm | In distribution |
| 58913555 | Length 55 mm | In distribution |
| 5351135022 | Non-Locking | In distribution |
| 58S13555 | Outer Diameter 3.5 mm | In distribution |
| 58S13524 | Length 24 mm | In distribution |
| 58913560 | Outer Diameter 3.5 mm | In distribution |
| 58S34012 | Outer Diameter 4 mm | In distribution |
| 520S000100 | Hole Qty: 6 | In distribution |
| 58S24028 | Length 28 mm | In distribution |
| 58813514 | Length 14 mm | In distribution |
| 58812730 | Length 30 mm | In distribution |
| 58813516 | Length 16 mm | In distribution |
| 5201124010 | Length 10 mm | In distribution |
| 5201000204 | Hole Qty: 7 | In distribution |
| 58S13520 | Length 20 mm | In distribution |
| 535S135034 | Length 34 mm | In distribution |
| 58S23516 | Outer Diameter 3.5 mm | In distribution |
| 535S035030 | Outer Diameter 3.5 mm | In distribution |
| 520S124016 | Outer Diameter 2.4 mm | In distribution |
| 5351035046 | Locking | In distribution |
| 520S000405 | Hole Qty: 5 | In distribution |
| 58S13530 | Length 30 mm | In distribution |
| 520S124014 | Length 14 mm | In distribution |
| 5351135048 | Outer Diameter 3.5 mm | In distribution |
| 535S135038 | Outer Diameter 3.5 mm | In distribution |
| 58S23542 | Length 42 mm | In distribution |
| 520S124026 | Outer Diameter 2.4 mm | In distribution |
| 58813542 | Outer Diameter 3.5 mm | In distribution |
| 58924024 | Outer Diameter 4 mm | In distribution |
| 5351035042 | Outer Diameter 3.5 mm | In distribution |
| 58813560 | Outer Diameter 3.5 mm | In distribution |
| 5201000306 | Hole Qty: 6 | In distribution |
| 5201120018 | Length 18 mm | In distribution |
| 58S44028 | Outer Diameter 4 mm | In distribution |
| 536S004001 | Medium | In distribution |
| 58944024 | Length 24 mm | In distribution |
| 58S24045 | Length 45 mm | In distribution |
| 58924035 | Length 35 mm | In distribution |
| 535S135032 | Outer Diameter 3.5 mm | In distribution |
| 58S13540 | Outer Diameter 3.5 mm | In distribution |
| 5201024024 | Outer Diameter 2.4 mm | In distribution |
| 535S035028 | Locking | In distribution |
| 58813555 | Outer Diameter 3.5 mm | In distribution |
| 58S12730 | Length 30 mm | In distribution |
| 5351035020 | Locking | In distribution |
| 5201020012 | Outer Diameter 2 mm | In distribution |
| 58913544 | Outer Diameter 3.5 mm | In distribution |
| 58813530 | Outer Diameter 3.5 mm | In distribution |
| 536S006002 | Large | In distribution |
| 58S23550 | Length 50 mm | In distribution |
| 535S135024 | Outer Diameter 3.5 mm | In distribution |
| 58S34014 | Length 14 mm | In distribution |
| 58S13526 | Outer Diameter 3.5 mm | In distribution |
| 58S12726 | Length 26 mm | In distribution |
| 5201020016 | Locking | In distribution |
| 5351135042 | Outer Diameter 3.5 mm | In distribution |
| 58S13518 | Outer Diameter 3.5 mm | In distribution |
| 520S120008 | Length 8 mm | In distribution |
| 58934014 | Length 14 mm | In distribution |
| 520S020012 | Outer Diameter 2 mm | In distribution |
| 5361004002 | Size: Large | In distribution |
| 5361006002 | Size: Large | In distribution |
| 58S24040 | Length 40 mm | In distribution |
| 58S23524 | Length 24 mm | In distribution |
| 58812718 | Outer Diameter 2.7 mm | In distribution |
| 58813536 | Outer Diameter 3.5 mm | In distribution |
| 58913514 | Outer Diameter 3.5 mm | In distribution |
| 520S024012 | Length 12 mm | In distribution |
| 58913516 | Outer Diameter 3.5 mm | In distribution |
| 5351135040 | Outer Diameter 3.5 mm | In distribution |
| 536S002000 | Small | In distribution |
| 5351135032 | Outer Diameter 3.5 mm | In distribution |
| 58S13528 | Length 28 mm | In distribution |
| 520S124020 | Non-Locking | In distribution |
| 535S035050 | Locking | In distribution |
| 58S13560 | Length 60 mm | In distribution |
| 58812714 | Length 14 mm | In distribution |
| 58813522 | Length 22 mm | In distribution |
| 58944026 | Outer Diameter 4 mm | In distribution |
| 535S035022 | Length 22 mm | In distribution |
| 520S024010 | Length 10 mm | In distribution |
| 5201000503 | Hole Qty: 4 | In distribution |
| 58S34026 | Length 26 mm | In distribution |
| 58S23530 | Outer Diameter 3.5 mm | In distribution |
| 58813532 | Outer Diameter 3.5 mm | In distribution |
| 58813524 | Outer Diameter 3.5 mm | In distribution |
| 58S34040 | Length 40 mm | In distribution |
| 536S004002 | Large | In distribution |
| 535S035055 | Outer Diameter 3.5 mm | In distribution |
| 5351135020 | Outer Diameter 3.5 mm | In distribution |
| 58S13550 | Outer Diameter 3.5 mm | In distribution |
| 535S035042 | Length 42 mm | In distribution |
| 5201120016 | Non-Locking | In distribution |
| 5361002000 | Size: Extra Small/Small | In distribution |
| 58934060 | Outer Diameter 4 mm | In distribution |
| 535S035038 | Outer Diameter 3.5 mm | In distribution |
| 58934020 | Outer Diameter 4 mm | In distribution |
| 58944040 | Length 40 mm | In distribution |
| 520S000204 | Hole Qty: 7 | In distribution |
| 536S006001 | Small | In distribution |
| 5201124014 | Length 14 mm | In distribution |
| 535S135022 | Outer Diameter 3.5 mm | In distribution |
| 58S34016 | Outer Diameter 4 mm | In distribution |
| 58813526 | Length 26 mm | In distribution |
| 58S13546 | Length 46 mm | In distribution |
| 5201124022 | Non-Locking | In distribution |
| 58812724 | Length 24 mm | In distribution |
| 58S24016 | Outer Diameter 4 mm | In distribution |
| 58944020 | Length 20 mm | In distribution |
| 5201120012 | Length 12 mm | In distribution |
| 520S120010 | Outer Diameter 2 mm | In distribution |
| 5201000304 | Hole Qty: 4 | In distribution |
| 520S124024 | Length 24 mm | In distribution |
| 535S035044 | Length 44 mm | In distribution |
| 58S13510 | Length 10 mm | In distribution |
| 520S000406 | Hole Qty: 6 | In distribution |
| 58S24030 | Outer Diameter 4 mm | In distribution |
| 5201024010 | Length 10 mm | In distribution |
| 58944035 | Outer Diameter 4 mm | In distribution |
| 58934040 | Length 40 mm | In distribution |
| 4942028L | Outer Diameter 2 mm | In distribution |
| 5351035038 | Length 38 mm | In distribution |
| 58S13522 | Outer Diameter 3.5 mm | In distribution |
| 58813548 | Outer Diameter 3.5 mm | In distribution |
| 58S13514 | Outer Diameter 3.5 mm | In distribution |
| 535S135044 | Outer Diameter 3.5 mm | In distribution |
| 520S020014 | Length 14 mm | In distribution |
| 58913518 | Outer Diameter 3.5 mm | In distribution |
| 5201000100 | Hole Qty: 6 | In distribution |
| 5201120020 | Outer Diameter 2 mm | In distribution |
| 4942020L | Outer Diameter 2 mm | In distribution |
| 5351135024 | Outer Diameter 3.5 mm | In distribution |
| 5351035048 | Outer Diameter 3.5 mm | In distribution |
| 5361004001 | Size: Medium | In distribution |
| 520S124018 | Length 18 mm | In distribution |
| 520S024018 | Length 18 mm | In distribution |
| 535S035048 | Outer Diameter 3.5 mm | In distribution |
| 58S13538 | Length 38 mm | In distribution |
| 535S035032 | Outer Diameter 3.5 mm | In distribution |
| 58S13536 | Outer Diameter 3.5 mm | In distribution |
| 58S12720 | Length 20 mm | In distribution |
| 58S13548 | Length 48 mm | In distribution |
| 58813520 | Outer Diameter 3.5 mm | In distribution |
| 58S24035 | Length 35 mm | In distribution |
| 58813534 | Length 34 mm | In distribution |
| 535S035034 | Locking | In distribution |
| 5351035034 | Length 34 mm | In distribution |
| 5201000206 | Hole Qty: 6 | In distribution |
| 5351135030 | Length 30 mm | In distribution |
| 58813544 | Length 44 mm | In distribution |
| 58913550 | Outer Diameter 3.5 mm | In distribution |
| 58812720 | Length 20 mm | In distribution |
| 5201024026 | Length 26 mm | In distribution |
| 520S124022 | Length 22 mm | In distribution |
| 58913536 | Length 36 mm | In distribution |
| 58813528 | Length 28 mm | In distribution |
| 520S120020 | Outer Diameter 2 mm | In distribution |
| 58S13544 | Outer Diameter 3.5 mm | In distribution |
| 58S13532 | Length 32 mm | In distribution |
| 58S13534 | Outer Diameter 3.5 mm | In distribution |
| 520S120018 | Non-Locking | In distribution |
| 58813512 | Outer Diameter 3.5 mm | In distribution |
| 520S000304 | Straight | In distribution |
| 58S13542 | Outer Diameter 3.5 mm | In distribution |
| 58944045 | Length 45 mm | In distribution |
| 5351135038 | Length 38 mm | In distribution |
| 5201020008 | Length 8 mm | In distribution |
| 58813510 | Length 10 mm | In distribution |
| 58934045 | Outer Diameter 4 mm | In distribution |
| 5351035036 | Length 36 mm | In distribution |
| 58813538 | Length 38 mm | In distribution |
| 58S13516 | Length 16 mm | In distribution |
| 5201120010 | Length 10 mm | In distribution |
| 5351135012 | Outer Diameter 3.5 mm | Withdrawn |
| 5351035014 | Outer Diameter 3.5 mm | Withdrawn |
| 58924016 | Length 16 mm | Withdrawn |
| 58924022 | Length 22 mm | Withdrawn |
| 4942035L | Outer Diameter 2 mm | Withdrawn |
| 5351035012 | Outer Diameter 3.5 mm | Withdrawn |
| 5351135018 | Length 18 mm | Withdrawn |
| 5351035016 | Length 16 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Wright Medical Technology, Inc. | 510(k) number | 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 40 units | 2020-11-03 |
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 |
|---|---|---|---|---|---|
| 2023-04-10 | Class II | Employee error | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. | 50 units | |
| 2023-04-10 | Class II | Employee error | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. | 41 units | |
| 2023-02-02 | Class II | Employee error | Stryker has identified an issue that impacts two specific lots of CLAW” II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contai | 10 units | |
| 2023-02-02 | Class II | Employee error | Stryker has identified an issue that impacts two specific lots of CLAW” II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contai | 4 units | |
| 2022-02-15 | Class II | Process control | An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw. | 1 package | 2022-10-05 |
| 2022-02-09 | Class II | Packaging process control | Product was labelled with the incorrect manufacturing and distribution dates. | 12 units | 2024-01-25 |
| 2021-12-03 | Class II | Under Investigation by firm | Incorrect product is contained in the packaging. | 22 units | |
| 2021-12-03 | Class II | Under Investigation by firm | The incorrect product is contained in the packaging. | 23 units | |
| 2021-12-03 | Class II | Under Investigation by firm | The incorrect product is contained in the packaging. | 250 units | |
| 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 30 units | 2020-11-03 |
| 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 42 units | 2020-11-03 |
| 2015-07-21 | Class II | Employee error | These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction. | 5687 units | 2018-08-01 |
| 2015-07-21 | Class II | Employee error | These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction. | 107 units | 2018-08-01 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 167 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 100 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 233 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. | 52 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. | 92 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 142 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 242 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 270 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 128 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 138 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 102 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 372 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. | 51 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. | 151 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 308 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 172 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 148 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 102 units | 2018-08-05 |
| 2015-03-06 | Class II | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction | 301 units | 2018-08-05 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 0 | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 50 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 1127 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 400 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 9 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 178 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 18 units | 2018-06-15 |
| 2014-07-30 | Class II | Device Design | Plates manufactured from an incorrect raw material. | 66 units | 2018-06-15 |
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.