Flower Orthopedics Corporation
FDA Regulatory Profile
Flower Orthopedics Corporation appears in FDA public data with 16 recalls, 8 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0074-2024, Class II) was initiated on August 29, 2023. Its most recent 510(k) clearance was granted on October 7, 2020.
Summary
- Total Recalls
- 16
- 510(k) Clearances
- 8
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0074-2024 | Class II | Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently ope | August 29, 2023 |
| Z-0448-2022 | Class II | Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter | November 2, 2021 |
| Z-0034-2022 | Class II | Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 | September 3, 2021 |
| Z-0111-2022 | Class II | Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any p | September 1, 2021 |
| Z-0114-2022 | Class II | Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate | September 1, 2021 |
| Z-0112-2022 | Class II | Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any pla | September 1, 2021 |
| Z-0113-2022 | Class II | Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7 | September 1, 2021 |
| Z-1698-2021 | Class II | T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intende | April 15, 2021 |
| Z-2783-2020 | Class II | Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be use | July 8, 2020 |
| Z-2786-2020 | Class II | Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be us | July 8, 2020 |
| Z-2782-2020 | Class II | Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used | July 8, 2020 |
| Z-2787-2020 | Class II | Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be use | July 8, 2020 |
| Z-2784-2020 | Class II | Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used | July 8, 2020 |
| Z-2785-2020 | Class II | Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be use | July 8, 2020 |
| Z-1113-2017 | Class II | Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set. | December 22, 2016 |
| Z-1314-2015 | Class II | Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Vari | February 16, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K192949 | Flower Suture Anchor Set | October 7, 2020 |
| K170687 | Flower Bone Screw Set | June 6, 2017 |
| K142306 | Flower Upper Extremity Plating Set | September 15, 2014 |
| K133930 | FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET | March 27, 2014 |
| K133102 | FLOWER ANKLE PLATING SET | November 18, 2013 |
| K132248 | FLOWER BONE SCREW SET | October 30, 2013 |
| K131657 | FLOWER SMALL AND MEDIUM IMPLANT SET | August 22, 2013 |
| K123562 | FLOWER SMALL AND MEDIUM BONE IMPLANTS | March 29, 2013 |