Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary
Summary
The FDA issued a Class II for Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream by Flower Orthopedics Corporation. Reason: Device is breaking while in use, potential for patients to require a revision surgery..
Details
Source
Device Recall
External ID
Z-0074-2024
Action Date
2023-10-18
Status
Ongoing
Category
device
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
Lot/Code Info: UDI:00840118117432 Lot Number: 2304323076
Quantity Affected: 70 units
Reason for Recall
Device is breaking while in use, potential for patients to require a revision surgery.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-29
Company
Horsham, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Flower Orthopedics Corporation has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Flower Orthopedics Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Flower Orthopedics Corporation have FDA actions?
Flower Orthopedics Corporation has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0074-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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