Zavation 10G Beveled Trocar/Cannula recalled for inadequate sterilization
Zavation is recalling 10G Beveled Trocar/Cannula surgical instruments distributed nationwide because they may not have been adequately sterilized. Patients who received these instruments in orthopedic or spinal procedures should consult their healthcare provider.
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 a surgical instrument with a serious potential hazard—inadequate sterilization in a high-risk surgical application (spinal and orthopedic procedures). No illnesses or injuries have been reported. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zavation is recalling its 10G Beveled Trocar/Cannula, a surgical instrument used in orthopedic and spinal procedures. The product was distributed as sterile throughout the United States.
The recall was initiated because these products may not have been adequately sterilized prior to distribution, despite being marketed and distributed as sterile.
Patients who received this instrument in orthopedic or spinal procedures should consult their healthcare provider if they have concerns about potential exposure. Healthcare facilities and surgical centers that received this product should identify affected units in their inventory and follow any guidance issued by the FDA or the manufacturer.
The recalled product
- Product
- 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
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)
- Pending
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 →Related recalls
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