11G Beveled Trocars and Cannulas Recalled for Possible Inadequate Sterilization
Zavation is recalling 11G Beveled Trocars/Cannulas for orthopedic and spinal procedures. These surgical instruments may not have been adequately sterilized, posing a potential safety risk.
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: This is an FDA Class II recall for surgical instruments that may not have been adequately sterilized. No reported injuries or hospitalizations are documented in the source. However, non-sterile surgical instruments present a significant risk of infection to surgical patients, meeting the criteria for a risk-of-harm product without yet-reported injury.
Plain-English summary
Zavation is recalling 11G Beveled Trocars/Cannulas for orthopedic and spinal surgical procedures. These instruments are intended to be sterile and for single-use application.
The recall was initiated because the distributed products may not have been adequately sterilized. The FDA classified this as a Class II recall. The affected instruments were distributed nationwide in the United States.
Non-sterile surgical instruments present a potential risk of infection to patients.
The recalled product
- Product
- 11G 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.
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