Horsham, PA, United States
Flower Orthopedics Corporation recalls
6 recalls recorded since 2018, most recently on 29 August 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)1
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 August 2023
- Reason
- Device is breaking while in use, potential for patients to require a revision surgery.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0074-2024
- 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
Terminated Class II Medical devices
- Recall started
- 2 November 2021
- Terminated
- 12 October 2023
- Reason
- Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0448-2022
- 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:
Terminated Class II Medical devices
- Recall started
- 3 September 2021
- Terminated
- 28 July 2022
- Reason
- Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0034-2022
- Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Terminated Class II Medical devices
- Recall started
- 1 September 2021
- Terminated
- 16 February 2023
- Reason
- Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
- Distribution
- Arizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas Virginia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0111-2022, Z-0114-2022, Z-0112-2022, Z-0113-2022
- 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. me
- 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
- 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
- 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
Terminated Class II Medical devices
- Recall started
- 15 April 2021
- Terminated
- 12 November 2021
- Reason
- Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
- Distribution
- US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1698-2021
- 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
Terminated Class II Medical devices
- Recall started
- 8 July 2020
- Terminated
- 8 October 2020
- Reason
- The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
- Distribution
- US Nationwide distribution including in the states of AZ, FL, and OH.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2783-2020, Z-2787-2020, Z-2785-2020, Z-2782-2020, Z-2786-2020, Z-2784-2020
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.