Flex-Thread Inserter Shaft intended for Fibula… recallZ-0448-2022 · Flower Orthopedics Corporation · initiated Nov 2, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Flower Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-0448-2022
- Status
- Terminated
- Initiated by the company
- Nov 2, 2021
- Recalling firm
- Flower Orthopedics Corporation
- Quantity
- 48 units
- Product code
- HSB
- FDA submissions
- K202858
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.
Product description
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
Code information (models, lots, serial numbers)
Lot Number: 11090 UDI: 00840118117548
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Inserter Shaft, Flex-Thread™ 8435-1Flower Orthopedics Corporation · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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