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 Flex-Thread Inserter Shaft Recall: Incompatibility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61605-flower-orthopedics-flex-thread-inserter-shaft-recall-incompatibility-risk. Based on FDA recall #Z-0448-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0448-2022%22&limit=1).
Flower Orthopedics Corporation voluntarily recalled the Flex-Thread Inserter Shaft on Nov. 2, 2021, according to the FDA. The device poses a hazard of mating incompatibility that may prevent surgeons from completing surgery.
How to tell if you have it
Brand: Flower Orthopedics
Product: Flex-Thread Inserter Shaft intended for Fibula intramedullary
Catalog Number: 8435-1
Lot Number: 11090
UDI: 00840118117548
The hazard
The recall cites mating incompatibility between the Inserter Shaft and the Inserter Draw Rod. This defect causes the rod to bind and not rotate freely as intended. As a result, a surgeon may be unable to complete surgery unless a second set is available.
Context
GovInfoNow's records show Flower Orthopedics Corporation has issued five other recalls since July 8, 2020. Other recent recalls of similar products include Arrow FLEXTIP Plus Epidural Catheter Recall (March 11, 2026) and Medicrea IB3D PL Instruments Set Recall (Oct. 29, 2025).
How to tell if you have this one
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.
Brand
Flower Orthopedics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for catalog number 8435-1 and lot number 11090 on the Flex-Thread Inserter Shaft.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Georgia, Illinois, Maryland, Massachusetts, North Carolina, Tennessee, Texas.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0448-2022 (November 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0448-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.