Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used Recalled by Flower Orthopedics Corporation Due to Mating incompatibility between the Inserter Shaft and the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Flower Orthopedics Corporation directly.
Affected Products
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
Quantity: 48 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Flower Orthopedics Corporation
Flower Orthopedics Corporation has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report