FDA Medical Device Recalls (openFDA)
Flower Orthopedics Corporation: 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
- Recall number
- Z-0448-2022
- Recalling firm
- Flower Orthopedics Corporation
- 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
- Status
- Terminated
- Initiated
- 2021-11-02
- Posted
- not on file
- Terminated
- 2023-10-12
- 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
- Root cause
- Device Design
- Action
- 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
- Quantity
- 48 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.
- Lot, serial or model codes
- Lot Number: 11090 UDI: 00840118117548
- 510(k) numbers
- ["K202858"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3009996260
- Firm city
- Horsham
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28