Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated… recallZ-0074-2024 · Flower Orthopedics Corporation · initiated Aug 29, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Flower Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Device is breaking while in use, potential for patients to require a revision surgery.
FDA root cause category: Under Investigation by firm
What the company is doing
Flowers initiated communication via email with a quarantine form on 08/29/2023. A notification packet detailing parameters of recall was issued on (09/1/2023) via certified mail. Letter states reason for recall, health risk and action to take: Immediately quarantine lot 2304323076 if not already segregated after quarantine notice sent on 08/28/2023. Return Product to Conventus Flower headquarters at 100 Witmer Rd Suite 280, Horsham, PA 19044. This advisory notice only includes the lot identified above. It does NOT affect other lots. You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form by mail or by email at [email protected]. For further information contact Christina Rovaldi, Sr. Manager RA/QA [email protected]. Return the attached Acknowledgement and Receipt Form mail or by email to [email protected]. Company contact hours are Monday through Friday, 8:30 AM to 5:00 PM, Eastern Time
Recall details
- Recall number
- Z-0074-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 29, 2023
- Posted by the FDA
- Oct 6, 2023
- Recalling firm
- Flower Orthopedics Corporation
- Quantity
- 70 units
- Product code
- HSB
- FDA submissions
- K202858
- Distribution
- US Nationwide distribution.
Product description
Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
Code information (models, lots, serial numbers)
UDI:00840118117432 Lot Number: 2304323076
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cannulated Reamer, 3.2mm, AO Quick Connect, Flex-Thread™ 8528-1-SFlower Orthopedics Corporation · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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