Z-1188-2016 Class II Terminated

Recalled by Richard Wolf Medical Instruments Corp. — Vernon Hills, IL

Recall Details

Product Type
Devices
Report Date
March 23, 2016
Initiation Date
February 29, 2016
Termination Date
July 3, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
108 units

Product Description

The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.

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.

Distribution Pattern

Nationwide Distribution including Virginia, Pennsylvania, Florida, California, Texas, North Carolina and Illinois.

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.