The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2273-2020·Announced 2020-06-17

Genicon Natura Cannula Recall Due to Detachable Optical Tip

Genicon, Inc. is recalling Natura Model 210-005-051 cannulas because the plastic optical tip may detach from the metal shaft.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural defects in medical devices that could lead to significant injury.

Plain-English summary

Genicon, Inc. is recalling Lot I8003-A of the Natura Model 210-005-051 cannula. The product consists of 5mm diameter, 70mm length threaded cannulas, distributed in boxes of 5 units. The recall involves 3 boxes (15 units total) that were shipped to consignees in the United States and various foreign countries.

The recall is being conducted because there is a potential for the plastic optical tip to become detached from the metal shaft. This defect could compromise the integrity of the device during use. The agency has classified this as a Class II recall.

Healthcare providers and consumers who possess this specific lot of the Genicon Natura cannula should stop using the product immediately. They should contact Genicon, Inc. for further instructions on how to return or dispose of the affected units.

The recalled product

Product
Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Manufacturer
Genicon, Inc.
Category
Medical Device — Surgical Instruments
Hazard

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 (1)

  • Lot I8003-A (nonsterile samples made for sales)

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 14 recalled by Genicon, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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