Class 2 Device Recall Richard Wolf Medical Instruments Corporation

• Date Initiated by Firm: February 29, 2016
• Create Date: July 09, 2019
• Recall Status: Terminated on July 03, 2019
• Recall Number: Z-1188-2016
• Recall Event ID: 73348
• Product Classification: Camera, television, microsurgical, with audio - Product Code FWE
• Product: The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.
• Code Information: FLEXION-PORT 400 (68cm) with Product number 32116068 and the following affected serial numbers: 001X001107, 001X001108, 001X001109, 001X001110, 001X001111, 001X001142, 001X001143, 001X001144, 001X001145, 001X001146, 001X001147, 001X001148, 001X001149, 001X001150, 001X001151, 001X001168, 001X001169, 001X001170, 001X001171, 001X001172, 001X001216, 001X001217, 001X001218, 001X001219, 001X001220, 001X001221, 001X001222, 001X001223, 001X001224, 001X001225, 001X001226, 001X001227, 001X001228, 001X001230, 001X001256, 001X001257, 001X001258, 001X001259, 001X001260, 001X001261, 001X001262, 001X001263, 001X001264, 001X001265, 001X001376, 001X001377, 001X001378, 001X001379, 001X001380, 001X001381, 001X001382, 001X001383, 001X001384, 001X001385 and 001X001229. FLEXION-PORT 300+350 (93cm) with Product number 32116093 and the following affected serial numbers: 001X001173, 001X001174, 001X001175, 001X001176, 001X001177, 001X001235, 001X001237, 001X001239, 001X001299, 001X001309, 001X001310, 001X001313, 001X001314, 001X001315, 001X001366, 001X001367, 001X001368, 001X001369, 001X001370, 001X001371, 001X001372, 001X001373, 001X001374, 001X001375, 001X001402, 001X001403, 001X001406, 001X001231, 001X001232, 001X001233, 001X001234, 001X001236, 001X001238, 001X001240, 001X001296, 001X001297, 001X001298, 001X001300, 001X001301, 001X001302, 001X001303, 001X001304, 001X001305, 001X001306, 001X001307, 001X001308, 001X001311, 001X001312, 001X001404, 001X001405, 001X001439, 001X001440, 001X001441, 001X001442, 001X001443, 001X001444, 001X001445, 001X001446, 001X001447 and 001X001448. FLEXION-PORT 400+350 (103cm) with Product number 32116103 and the following affected serial numbers: 001X001241, 001X001242, 001X001243, 001X001244, 001X001245, 001X001246, 001X001247, 001X001248, 001X001249, 001X001250, 001X001321, 001X001323, 001X001324, 001X001325, 001X001336, 001X001337, 001X001338, 001X001339, 001X001340, 001X001341, 001X001342, 001X001343, 001X001344, 001X001345, 001X001316, 001X001317, 001X001318, 001X001319, 001X001320 and 001X001322.
• Recalling Firm/ Manufacturer: Richard Wolf Medical Instruments Corp.; 353 Corporate Woods Pkwy; Vernon Hills IL 60061-3110
• For Additional Information Contact: Lisa Williams; 847-913-1113
• Manufacturer Reason for Recall: Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.
• FDA Determined Cause: Process control
• Action: RICHARD WOLF sent an Urgent Safety Information letter dated March 2, 2016, to all affected consignees. The letter described the nature of the recall regarding the monitor holding plate (VESA 75/100 mount) in our Flexion-Port 300, 350 and 400 swivel arm product series. According to the firm insufficient riveting of the rotation elements the rivets may loosen during continuous use (e.g. when adjusting the tilt angle) and in an extremely unlikely event the monitor holding plate (VESA 75/100 mount) may loosen. According to Richard Wolf this can result in a potential danger for the patient, user and others which we want to prevent with this measure. The firm is asking all end users to take the following step: Discontinue use of the affected devices until the conversion kits have been installed by a qualified service technician. Make sure that all users of affected medical devices are informed in their organization of the urgent safety information. If the end user has passed on products to third parties they should pass on a copy of this information and inform the recall contact person at Richard Wolf. Please make sure that the information is observed at their organization until all necessary internal measures have been completed. The end user should provide confirmation of receipt of this urgent safety information and answer the enclosed questionaire form which the firm asks to send to Richard Wolf at the following e-mail, marek.rast@richard-wolf.com by February 22, 2016. The firm asking that recipients to acknowledge receipt of the safety information in order to avoid receiving more reminders from Richard Wolf. The firm will send new monitor holding plate(s}, (643301264 conversion kit for monitor holding plate) once the form is received. The firm asks that qualified service technician install the new monitor holding plate (643301264 Conversion kit for monitor holding plate) in accordance with the enclosed assembly instructions and discard
• Quantity in Commerce: 108 units
• Distribution: Nationwide Distribution including Virginia, Pennsylvania, Florida, California, Texas, North Carolina and Illinois.
• 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.