Agency classClass IIOur severity:High FDA (Devices)·Z-1719-2021·Announced 2021-06-09

Zavation Direct Working Cannula Recalled for Sterilization Defect

Zavation is recalling 58 units of 11G Direct Working Cannula Diamond Tip Mini devices (Lot 2002437) because they may not have been adequately sterilized before distribution.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall for inadequate sterilization of surgical instruments. The source text does not report any illnesses, injuries, or hospitalizations. However, the recalled devices are surgical cannulas intended for invasive spinal procedures, and inadequate sterilization poses an inherent risk of serious infection. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Zavation has initiated a recall of 58 units of 11G Direct Working Cannula Diamond Tip Mini devices (Product Code: INTVMN-DWCD, Lot 2002437). The devices were distributed nationwide in the United States for use in orthopedic and spinal surgical procedures.

These cannulas were distributed as sterile medical devices. Upon review, the FDA determined that the products may not have been adequately sterilized prior to distribution. Non-sterile surgical instruments can pose a risk of serious infection when used in invasive procedures.

Healthcare facilities and providers who received Lot 2002437 should review their inventory to identify any affected units. Individuals and facilities with concerns about received units should contact Zavation or the FDA for guidance.

The recalled product

Product: 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
Manufacturer: Zavation
Category: Medical Device — Orthopedic / Surgical
Hazard: sterilization-defect
infection-risk
Affected units: 58

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: 2002437

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 71 recalled by Zavation 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 71 products in this recall →

Same manufacturer · Zavation

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Same hazard · sterilization defect