Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Flower Orthopedics with 16 device recalls and 12 510(k) clearances. The most recent is a 510(k) clearance dated Aug 24, 2026: OsteoCoil™ GT Active Compression System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 24, 2026 | OsteoCoil™ GT Active Compression SystemK260106 · HWC | 510(k) clearances |
| Nov 22, 2024 | OsteoCoil™ Nitinol Compression System (Multiple Component PNs)K233567 · HWC | 510(k) clearances |
| Aug 29, 2023 | Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropClass II · Device is breaking while in use, potential for patients to require a revision surgery. | Device recalls |
| Nov 21, 2022 | Flex-Thread™ Ulna Intramedullary Nail SystemK222390 · HSB | 510(k) clearances |
| Nov 2, 2021 | Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in ordClass II · Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and no | Device recalls |
| Sep 3, 2021 | Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201Class II · Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced) | Device recalls |
| Sep 1, 2021 | Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of thClass II · Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Device recalls |
| Sep 1, 2021 | Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and MeClass II · Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Device recalls |
| Sep 1, 2021 | Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and MediuClass II · Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Device recalls |
| Sep 1, 2021 | Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Class II · Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Device recalls |
| Jul 23, 2021 | Flex-Thread™ Distal Fibula lntramedullary Nail SystemK212030 · HSB | 510(k) clearances |
| Apr 15, 2021 | T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 dClass II · Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and addition | Device recalls |
| Oct 7, 2020 | Flower Suture Anchor SetK192949 · MBI | 510(k) clearances |
| Jun 6, 2017 | Flower Bone Screw SetK170687 · HWC | 510(k) clearances |
| Sep 15, 2014 | Flower Upper Extremity Plating SetK142306 · HRS | 510(k) clearances |
| Mar 27, 2014 | FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SETK133930 · HRS | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
