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U.S. Department of Health and Human Services

Class 2 Device Recall Flower Rearfoot Plating Set

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  Class 2 Device Recall Flower Rearfoot Plating Set see related information
Date Initiated by Firm July 08, 2020
Date Posted August 12, 2020
Recall Status1 Terminated 3 on October 08, 2020
Recall Number Z-2784-2020
Recall Event ID 86023
510(K)Number K133930  
Product Classification Plate, fixation, bone - Product Code HRS
Product Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
Code Information Lot Number 1909660033; UDI 00840118115667
Recalling Firm/
Manufacturer		 Flower Orthopedics Corporation
100 Witmer Rd Ste 280
Horsham PA 19044-2647
For Additional Information Contact Robin Fatzinger
215-394-8903
Manufacturer Reason
for Recall		 The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The Regional Business Director notified the customer by telephone and informed them that there was an issue with the newly released calcaneus plates. The 6 units were requested to be returned to Flower Orthopedics.
Quantity in Commerce 25
Distribution US Nationwide distribution including in the states of AZ, FL, and OH.
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.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = FLOWER ORTHOPEDICS CORPORATION
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