The Recall Desk

Manufacturer

Flower Orthopedics Corporation

16 recalls in our database name Flower Orthopedics Corporation as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
1
Most recent
2023-10-18

Of the 16 recalls from Flower Orthopedics Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • HighFDA (Devices)·Z-0074-2024·2023-10-18

    Flower Orthopedics Cannulated Reamer Recalled for Breaking During Surgical Use

    The FDA is recalling Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer because the device can break during use, potentially requiring revision surgery.

    Product
    Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0448-2022·2022-01-12

    Orthopedic Inserter Shaft Recalled for Mating Incompatibility During Surgery

    Flower Orthopedics is recalling 48 units of the Flex-Thread Inserter Shaft due to mating incompatibility with the Inserter Draw Rod. The defect may cause the draw rod to bind during fibula intramedullary nail insertion, potentially preventing surgery completion.

    Product
    Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0112-2022·2021-10-20

    Flower Drill Bit Kit 2.4mm missing AO connect feature

    Flower Orthopedics Corporation is recalling 33 units of its 2.4mm Drill Bit Kit (Lot 2101321194) because the drill bits lack the AO connect feature, which may delay surgical procedures.

    Product
    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 Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0113-2022·2021-10-20

    Flower Drill Bit Kit Missing AO Connect Feature, May Delay Procedures

    Flower Orthopedics Corporation is recalling Flower Drill Bit Kit 2.7mm (DBK 027) due to missing AO connect feature that may delay surgical procedures. Affected kits were distributed across multiple U.S. states.

    Product
    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 Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0111-2022·2021-10-20

    Flower Drill Bit Kit missing AO connect feature may delay procedures

    Flower Orthopedics is recalling Flower Drill Bit Kit 2.0 mm kits because drill bits are missing the AO connect feature, which may result in procedural delays. Affected units were distributed across multiple states.

    Product
    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 the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0114-2022·2021-10-20

    Flower Lag Screw Kit drill bits missing AO connect feature recalled

    Flower Orthopedics is recalling Flower Lag Screw Kit 2.7 mm because drill bits lack the AO connect feature, which may delay surgical procedures.

    Product
    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 Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the med
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0034-2022·2021-10-13

    Flower E-Kit bone fixation kits recalled due to missing surgical component

    Flower Orthopedics is recalling 77 Flower E-Kit bone fixation kits because they are missing a required CDG 200 Cannulated Countersink component. The incomplete kits could compromise orthopedic surgical procedures.

    Product
    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2021·2021-06-09

    T25 Cannulated Screwdrivers May Break During Surgical Procedures

    T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits may break at the driver tip during use, extending surgery time and requiring additional imaging to identify fragments.

    Product
    T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 calcaneus plates because the contract manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2786-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because the manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2787-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 Calcaneus Plates, Extensile, Large, Right (Catalog Number CPF 203) because the contract manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2782-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because they were manufactured with a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2784-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 calcaneus plates because the manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2783-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because they were manufactured with a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2015·2015-04-01

    Flower Orthopedics Recalls Variable Angle Locking Pegs Due to Failure

    Flower Orthopedics is recalling 901 Variable Angle Locking Pegs because they failed to lock during distal radius procedures, resulting in one scheduled revision surgery.

    Product
    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:
    Category
    Medical Device
    Distribution
    9 states