The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2279-2020·Announced 2020-06-17

Genicon Natura Trocar Recall Due to Potential Tip Detachment

Genicon, Inc. is recalling Natura Model 210-005-052 trocars 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when structural defects in medical devices present a risk of harm.

Plain-English summary

Genicon, Inc. is recalling the Natura Model 210-005-052, a 5mm diameter, 70mm length two-cannula threaded trocar. The product is identified by Lot I9524-A. The recall involves 24 boxes with 5 units per box in inventory.

The recall is being issued because there is a potential for the plastic optical tip to become detached from the metal shaft. This is classified as an FDA Class II recall.

The product was distributed to consignees in the United States (AL, DE, FL, GA, MO, NC, TN) and foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand. Users should stop using the affected devices and contact the manufacturer for instructions.

The recalled product

Product
Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two 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 Instrument
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 I9524-A

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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