Class 2 Device Recall Parietex

• Date Initiated by Firm: January 11, 2023
• Date Posted: February 27, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1183-2023
• Recall Event ID: 91567
• 510(K)Number: K173796
• Product Classification: Mesh, surgical, polymeric - Product Code FTL
• Product: Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe-; Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair; Model Number: PCO2H3
• Code Information: GTIN: A8845211784602 Lot Number: PVE0194M
• Recalling Firm/ Manufacturer: Covidien, LP; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: Medtronic Customer Service ; 800-962-9888
• Manufacturer Reason for Recall: Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant
• FDA Determined Cause: Under Investigation by firm
• Action: Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" letter on Jan 11, 2023, to Risk Manager/Healthcare Professional/Distributor via UPS 2-day delivery. For outside United States. OUS countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and actions to take: Identify and quarantine all unused and non-expired product from the affected lot (PVE0194M) of Parietex" Composite Mesh. If Parietex" Composite Mesh with collagen film on the wrong side is encountered in the operating room setting, please discard the product and use additional, correct mesh product instead. In the event it is determined by a medical facility that an affected product was implanted during a procedure, that facility should follow its medical record management procedures to ensure that this recall condition is properly noted for that procedure and documented to ensure traceability. Please complete the enclosed Customer Confirmation Form (even if your account no longer has unused and non-expired product from the affected lot (PVE0194M) on hand) and email to rs.gmbfcamitg@medtronic.com. Return all unused and non-expired product from the affected lot in your inventory to: Medtronic, Attn: Field Returns Dept. 195 McDermott Road, North Haven, CT 06473 USA. If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888, Option 2. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product within the specified lot has been transferred or distributed. Shipping and Return Instructions: For product purchased directly from Medtronic, please contact rs.covidienfeedbackcustomerservice@medtronic.com for Return Good Authorization (RGA). Credit or Replacement for the returned affected product will be issued based on the RGA number. If purchased from a distributor, contact your distributor directly
• Quantity in Commerce: 53 units
• Distribution: US Distribution to states of: CA, GA, NY and OUS Foreign distribution to countries of: Armenia, Belgium, France, Germany, Israel, Japan, Luxembourg, Romania, Spain, Switzerland and United Kingdom.
• 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 = FTL and Original Applicant = Sofradim Production