Recall Z-0448-2022
Flower Orthopedics Corporation · initiated November 2, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Number: 11090 UDI: 00840118117548
Reason for recall
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
FDA-determined cause: Device Design
Action taken
Conventus Flower Orthopedics issued Urgent Recall Information letter dated 11/2/21 stating reason for recall, health risk and action to take: Check your inventory for the product listed below and immediately replace with the new product provided. 2.Next, please complete and return the attached Acknowledgement and ReceiptForm with the affected product in the provided packaging by November 5, 2021. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or FLOWERCS@FLOWERORTHO.COM
Details
- Recall number
- Z-0448-2022
- Initiated
- November 2, 2021
- Terminated
- October 12, 2023
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 48 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.
- Recalling firm
- Flower Orthopedics Corporation, Horsham, PA