Flower Orthopedics recalls Flex-Thread Inserter Shaft for fibula intramedullary use due to incompatibility with Inserter Draw Rod causing binding during surgery. Affected units have specific catalog and lot numbers.
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
Flower Orthopedics is recalling Flex-Thread Inserter Shafts for fibula intramedullary procedures because they may not work properly with the Inserter Draw Rod, potentially preventing surgery completion. This is a serious issue for surgeons using these medical devices.
The Inserter Shaft and Inserter Draw Rod are designed to work together, but incompatibility causes the Draw Rod to bind and not rotate freely. This could prevent surgeons from completing surgery unless they have a second set available.
Surgeons using Flex-Thread Inserter Shafts for fibula intramedullary procedures are most at risk. Affected units were sold with specific catalog and lot numbers.
Check for catalog number 8435-1 and lot number 11090 on the Flex-Thread Inserter Shaft. These units were sold with the Blue Ratchet Handle for fibula intramedullary procedures.
Look for catalog number 8435-1 and lot number 11090 on the Flex-Thread Inserter Shaft.
The Inserter Shaft may not work properly with the Inserter Draw Rod, causing binding and preventing surgery completion unless a second set is available.
Check for catalog number 8435-1 and lot number 11090. If you have these numbers, contact Flower Orthopedics for guidance.
The hazard could prevent surgery completion, but the recall does not specify a risk of serious injury to patients.
We’ve drafted a message you can send Flower Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-0448-2022 — Flower Orthopedics Flower Orthopedics Hello, I own a Flower Orthopedics that is covered by recall Z-0448-2022 from Flower Orthopedics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
