Use cautionMedical device recall · FDA · Published August 29, 2023
Flower Orthopedics Flex-: Reamer may break during use, requiring revision surgery
Flower Orthopedics recalls 3.2mm Flex-Thread Reamers that may break during use, potentially requiring revision surgery. Affected units have specific catalog and lot numbers.
“Flower Orthopedics Flex-: Reamer may break during use, requiring revision surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57435-flower-orthopedics-flex-reamer-may-break-during-use-requiring-revision. Based on FDA recall #Z-0074-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0074-2024%22&limit=1).
Flower Orthopedics Corporation recalled the Coventus Flower Orthopedics Flex-Thread 3.2mm Cannulated Reamer on Aug. 29, 2023, according to the FDA. The device may break during use, potentially requiring patients to undergo revision surgery.
The device is breaking while in use, which poses a potential for patients to require a revision surgery. The reamer is used to open the intramedullary canal to the appropriate depth for nail insertion.
Context
GovInfoNow's records show Flower Orthopedics Corporation has five other recalls on record since July 8, 2020. Other recent recalls of similar products include the Zimmer Off-Axis Alliance Glenoid Reamer Guide Recall (May 20, 2026) and the Mentor Texas CPX 4 Breast Tissue Expanders recall (Feb. 18, 2026).
How to tell if you have this one
Check for the catalog number 8528-1-S or lot number 2304323076 on the reamer. The device is a sterile, single-use surgical tool used to open the bone canal for nail insertion.
Brand
Flower Orthopedics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for catalog number 8528-1-S or lot number 2304323076 on the reamer.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0074-2024 (August 29, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0074-2024 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.