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U.S. Department of Health and Human Services

Class 2 Device Recall FlexThread Inserter Shaft

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  Class 2 Device Recall FlexThread Inserter Shaft see related information
Date Initiated by Firm November 02, 2021
Create Date January 03, 2022
Recall Status1 Open3, Classified
Recall Number Z-0448-2022
Recall Event ID 89092
510(K)Number K202858  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product 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
Code Information Lot Number: 11090 UDI: 00840118117548
Recalling Firm/
Manufacturer		 Flower Orthopedics Corporation
100 Witmer Rd Ste 280
Horsham PA 19044-2647
For Additional Information Contact SAME
215-394-8903
Manufacturer 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
FDA Determined
Cause 2		 Device Design
Action Conventus Flower Orthopedics issued Urgent Recall Information letter dated 11/2/21 stating reason for recall, health risk and action to take: Check your inventory for the product listed below and immediately replace with the new product provided. 2.Next, please complete and return the attached Acknowledgement and ReceiptForm with the affected product in the provided packaging by November 5, 2021. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or FLOWERCS@FLOWERORTHO.COM
Quantity in Commerce 48 units
Distribution US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = Conventus Orthopaedics, LLC
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