Class 2 Device Recall CPS CALCANEAL PLATE SML 54MM

• Date Initiated by Firm: November 08, 2016
• Create Date: November 25, 2019
• Recall Status: Terminated on November 03, 2020
• Recall Number: Z-0573-2020
• Recall Event ID: 84180
• 510(K)Number: K061808
• Product Classification: Plate, fixation, bone - Product Code HRS
• Product: CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
• Code Information: Lot Number 1552873
• FEI Number: 1043534
• Recalling Firm/ Manufacturer: Wright Medical Technology, Inc.; 11576 Memphis Arlington Rd; Arlington TN 38002-9497
• Manufacturer Reason for Recall: The firm discovered a lack of adequate documentation confirming sterility on certain products.
• FDA Determined Cause: Process control
• Action: The firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units.
• Quantity in Commerce: 42 units
• Distribution: US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
• 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