Flower Orthopedics Corporation: Medical Device Recall in 2022 - (Recall #: Z-0448-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 2, 2021

Date Posted: January 12, 2022

Recall Number: Z-0448-2022

Event ID: 89092

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

Status: Terminated

Product Quantity: 48 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated