FDA-Device2022-01-12Class II
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
Flower Orthopedics Corporation
Hazard
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
Sold states
US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.
Affected count
48 units
Manufactured in
100 Witmer Rd Ste 280, N/A, Horsham, PA, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0448-2022Don't want to check this manually?
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