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U.S. Department of Health and Human Services

Class 2 Device Recall FlexThread TM 3.2mm Cannulated Reamer

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 Class 2 Device Recall FlexThread TM 3.2mm Cannulated Reamersee related information
Date Initiated by FirmAugust 29, 2023
Date PostedOctober 06, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0074-2024
Recall Event ID 93024
510(K)NumberK202858 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductCoventus 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 UDI:00840118117432 Lot Number: 2304323076
Recalling Firm/
Manufacturer		 Flower Orthopedics Corporation
100 Witmer Rd Ste 280
Horsham PA 19044-2647
For Additional Information ContactSAME
215-394-8903
Manufacturer Reason
for Recall		Device is breaking while in use, potential for patients to require a revision surgery.
FDA Determined
Cause 2		Under Investigation by firm
ActionFlowers 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 crovaldi@flowerortho.com. For further information contact Christina Rovaldi, Sr. Manager RA/QA crovaldi@flowerortho.com. Return the attached Acknowledgement and Receipt Form mail or by email to crovaldi@flowerortho.com. Company contact hours are Monday through Friday, 8:30 AM to 5:00 PM, Eastern Time
Quantity in Commerce70 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HSB
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