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U.S. Department of Health and Human Services

Class 2 Device Recall Flowers

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  Class 2 Device Recall Flowers see related information
Date Initiated by Firm April 15, 2021
Create Date June 01, 2021
Recall Status1 Terminated 3 on November 12, 2021
Recall Number Z-1698-2021
Recall Event ID 87906
Product Classification Screwdriver - Product Code HXX
Product T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm

Product Code: GWK 300
Code Information Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035  UDI: 00840118110853
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		 Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Flower Orthopedic issued Urgent Recall Information via email on 4/15/21. Letter states reason for recall, health risk and action to take: Check your inventory for the product listed below and quarantine immediately. Next, please complete and return the attached Acknowledgement and Receipt Form as soon as possible. Flower Orthopedics is initiating shipment of replacement product for delivery Friday April 16. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or FLOWERCS@FLOWERORTHO.COM "Acknowledgement and Product Replacement Forms (see attached)
Quantity in Commerce 47 units
Distribution US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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