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Recall Observatory FDA recall evidence

Device 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

Z-0448-2022

November 02, 2021

Class II

Product summary

Firm
Flower Orthopedics Corporation
Event
Event 89092
Status
Terminated
Classification
Class II
Quantity
48 units
Official record key
device-enforcement:Z-0448-2022

Official wording

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

Code information: Lot Number: 11090 UDI: 00840118117548

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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