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
FDA Recall Z-0448-2022 · Posted None
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Recalling FirmFlower Orthopedics Corporation
Recall StatusTerminated
Product CodeHSB
Date Initiated2021-11-02
Date Terminated2023-10-12
Product Quantity48 units
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
Firm 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 [email protected]
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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