Flower Orthopedics Flex-: Reamer may break during use, requiring revision surgery

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Recalling firmFlower Orthopedics Corporation100 Witmer Rd Ste 280, N/A · Horsham, PA 19044-2647

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Flower Orthopedics is recalling their Flex-Thread 3.2mm Cannulated Reamers because they can break during use, which might require patients to have revision surgery. This is a serious issue for people who have received this surgical tool.

Why it’s dangerous

The reamer can break while being used in surgery, which might require the patient to undergo additional surgery to fix the problem. This happens because the device is designed for single use and can fail during the procedure.

Who’s affected

Patients who received this reamer during surgery are most at risk. Medical professionals using the device for procedures may also be affected.

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.

✎ GovInfoNow

Questions people ask

Why is this reamer being recalled?

The reamer may break during use, which could require patients to have revision surgery.

How can I tell if I have the recalled reamer?

Check for catalog number 8528-1-S or lot number 2304323076 on the reamer.

What should I do if I have this reamer?

The recall record does not specify a remedy, so contact Flower Orthopedics for guidance.

Take action

Contact Flower Orthopedics

We’ve drafted a message you can send Flower Orthopedics to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0074-2024 — Flower Orthopedics Flower Orthopedics

Hello,

I own a Flower Orthopedics that is covered by recall Z-0074-2024 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.

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Where this comes from

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.

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