Flower Orthopedics Corporation

Complete recall history across all FDA and CPSC categories — 16 total recalls

Flower Orthopedics Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (16)

FDA medical device enforcement actions by Flower Orthopedics Corporation

Date Product Reason Class
Aug 29, 2023 Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to re... Device is breaking while in use, potential for patients to require a revision... Class II
Nov 2, 2021 Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be... Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod c... Class II
Sep 3, 2021 Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) fro... Class II
Sep 1, 2021 Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to... Drill bits packaged in kits are missing the AO connect feature and may result... Class II
Sep 1, 2021 Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and c... Drill bits packaged in kits are missing the AO connect feature and may result... Class II
Sep 1, 2021 Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can... Drill bits packaged in kits are missing the AO connect feature and may result... Class II
Sep 1, 2021 Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and... Drill bits packaged in kits are missing the AO connect feature and may result... Class II
Apr 15, 2021 T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) -... Cannulated Screwdrivers may break at the driver tip along the shaft, near the... Class II
Jul 8, 2020 Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usa... The contract manufacturer of the calcaneus plate inadvertently used the incor... Class II
Jul 8, 2020 Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product U... The contract manufacturer of the calcaneus plate inadvertently used the incor... Class II
Jul 8, 2020 Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usa... The contract manufacturer of the calcaneus plate inadvertently used the incor... Class II
Jul 8, 2020 Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incor... Class II
Jul 8, 2020 Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incor... Class II
Jul 8, 2020 Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incor... Class II
Dec 22, 2016 Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bo... The product is being recalled due to incidence and reports of the product bre... Class II
Feb 16, 2015 Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D... Locking pegs were not locking during distal radius procedures. There has been... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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