Moderate FDA (Devices)·Z-1188-2016·Announced 2016-03-23

Richard Wolf Vesa 75/100 Adaptation Recalled for Missing Rivets

Richard Wolf Medical Instruments Corp. is recalling 108 Vesa 75/100 adaptations with rotation because monitor mounts may be missing riveting.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths. The hazard is a structural defect (missing riveting) that poses a potential risk but has not resulted in reported harm, fitting the criteria for a moderate severity score.

Plain-English summary

Richard Wolf Medical Instruments Corp. is recalling 108 units of the Vesa 75/100 adaptation with rotation. This product is an accessory to a surgical camera intended to be used to record operative procedures. The recall was initiated because the supplier of the product, which is part of their monitor mounts and support arms, may be missing riveting.

The affected units were distributed nationwide, including in Virginia, Pennsylvania, Florida, California, Texas, North Carolina, and Illinois. The recall covers specific serial numbers for the FLEXION-PORT 400 (68cm), FLEXION-PORT 300+350 (93cm), and FLEXION-PORT 400+350 (103cm) models, identified by product numbers 32116068, 32116093, and 32116103 respectively.

Healthcare facilities and users should check their inventory for the affected serial numbers listed in the official recall notice. If a unit is found, it should be removed from service and returned to the manufacturer or their authorized representative for inspection or replacement.

The recalled product

Product: The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.
Manufacturer: Richard Wolf Medical Instruments Corp.
Category: Medical Device — Surgical Camera Accessory
Hazard: structural-defect
fall-hazard
Affected units: 108

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

001X001108
001X001109
001X001110
001X001111
001X001142
001X001143
001X001144
001X001145
001X001146
001X001147
001X001148
001X001149
001X001150
001X001151
001X001168
001X001169
001X001170
001X001171
001X001172
001X001216

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · Richard Wolf Medical Instruments Corp.

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Same hazard · structural defect