Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue R
Summary
The FDA issued a Class II for Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be us by Flower Orthopedics Corporation. Reason: Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended su.
Details
Source
Device Recall
External ID
Z-0448-2022
Action Date
2022-01-12
Status
Terminated
Category
device
Product Description
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
Lot/Code Info: Lot Number: 11090 UDI: 00840118117548
Quantity Affected: 48 units
Reason for Recall
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
Distribution
US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-02
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 114 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-0448-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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