Class 2 Device Recall VersaOne Reusable Positioning Cannula

• Date Initiated by Firm: March 22, 2023
• Date Posted: April 26, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1464-2023
• Recall Event ID: 92004
• 510(K)Number: K201805
• Product Classification: Laparoscope, general & plastic surgery - Product Code GCJ
• Product: VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
• Code Information: UDI-DI: 10884521784048; Serial Numbers: C20RSL0083 C20RSL0085 C20RSL0086 C20RSL0087 C20RSL0088 C20RSL0062 C20RSL0063 C20RSL0071 C20RSL0072 C20RSL0073 C20RSL0074 C20RSL0075 C20RSL0076 C20RSL0070 C21RSJ0012 C20RSL0066 C20RSL0080 C20RSL0095 C20RSL0098 C20RSL0077 C20RSL0078 C20RSL0097 C20RSJ0002 C20RSJ0003 C20RSJ0004 C21RSJ0001 C21RSJ0002 C21RSJ0003 C21RSJ0004 C21RSJ0005 C21RSJ0006 C21RSJ0009 C21RSJ0010 C21RSJ0011 C21RSJ0018 C21RSJ0019 C21RSJ0020 C21RSJ0021 C21RSJ0022 C21RSK0026 C21RSK0027 C21RSK0028 C21RSJ0030 C21RSK0001 C21RSK0002 C21RSJ0013 C21RSJ0014 C21RSJ0015 C21RSJ0016 C21RSK0015 C21RSK0025
• Recalling Firm/ Manufacturer: Covidien LP; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: Technical Service; 508-261 Ext. 8000
• Manufacturer Reason for Recall: There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
• FDA Determined Cause: Process control
• Action: An URGENT MEDICAL DEVICE RECALL notification letter dated March 2023 was sent to customers. Customer Actions: Our records show that your facility has received the impacted product. Medtronic requests that you take the following actions: " Identify and quarantine any used and unused impacted product. Please refer to Attachment A: Impacted Serial Number Lists for a list of affected products. For verifying the respective product and serial number on the device and packaging please refer to Attachment B. " Sterilize all used devices as per your standard decontamination protocol prior to returning used cannulas. Utilization of appropriate personal protective equipment is advisable during decontamination of the device. " Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. " Complete the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. " Forward this notification to any entities within your organization or to any other organization where the potentially affected product has been transferred or further distributed. Adverse events or quality problems experienced with this product should be reported to the FDA and Medtronic: " Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, or call FDA at 1-800-FDA-1088 (1-800-332-1088) " Medtronic Technical Services at 1-800-962-9888, option 2 to provide information regarding those events. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative.
• Quantity in Commerce: 51 units
• Distribution: Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
• 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 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) Database: 510(K)s with Product Code = GCJ