FDA recall Z-0448-2022

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

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

Distribution

US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.

Key facts

Status

Terminated

Initiation date

2021-11-02

Report date

2022-01-12

Termination date

2023-10-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0448-2022