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Flower Orthopedics Corporation FDA Recalls
8 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullaryClass IIAug 29, 2023Device is breaking while in use, potential for patients to r |
| Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue RClass IINov 2, 2021Mating incompatibility between the Inserter Shaft and the In |
| Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201Class IISep 3, 2021Product kit missing CDG 200 (Cannulated Countersink for 3.0- |
| 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 theClass IISep 1, 2021Drill bits packaged in kits are missing the AO connect featu |
| 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 beClass IISep 1, 2021Drill bits packaged in kits are missing the AO connect featu |
| 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 FlClass IISep 1, 2021Drill bits packaged in kits are missing the AO connect featu |
| 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 cClass IISep 1, 2021Drill bits packaged in kits are missing the AO connect featu |
| T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to inseClass IIApr 15, 2021Cannulated Screwdrivers may break at the driver tip along th |