The Recall Desk
HighFDA (Devices)·Z-0448-2022·Announced 2022-01-12

Orthopedic Inserter Shaft Recalled for Mating Incompatibility During Surgery

Flower Orthopedics is recalling 48 units of the Flex-Thread Inserter Shaft due to mating incompatibility with the Inserter Draw Rod. The defect may cause the draw rod to bind during fibula intramedullary nail insertion, potentially preventing surgery completion.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA medical device recall. The defect involves a critical surgical instrument where mating incompatibility could prevent proper device function during fibula intramedullary nail insertion. This represents a risk-of-harm product, placing it in the high-risk category per the severity rubric.

Plain-English summary

Flower Orthopedics Corporation is recalling 48 units of the Flex-Thread Inserter Shaft (Catalog Number 8435-1, Lot Number 11090) used in fibula intramedullary nail insertion procedures. The devices were distributed nationwide to facilities in Arizona, California, Colorado, Georgia, Tennessee, Florida, Illinois, Massachusetts, Maryland, North Carolina, and Texas.

The recalled inserter shaft has a mating incompatibility with the Inserter Draw Rod, causing the draw rod to bind and preventing normal rotation during use. This defect may cause surgeons to be unable to complete fibula intramedullary nail insertion surgery unless a backup set of instruments is available.

The FDA classified this as a Class II recall. Healthcare facilities that have received this device should stop using the affected lot and contact Flower Orthopedics Corporation for replacement units or return instructions. The affected lot number is 11090 (UDI: 00840118117548).

The recalled product

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
Manufacturer
Flower Orthopedics Corporation
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
  • mating-incompatibility
  • device-malfunction
  • surgical-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 11090 UDI: 00840118117548

Distribution

Distributed nationwide across the United States.

Related recalls

Same category