Class 2 Device Recall Flower Rearfoot Plating Set

• Date Initiated by Firm: July 08, 2020
• Date Posted: August 12, 2020
• Recall Status: Terminated 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
• FEI Number: 3009996260
• 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: 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