Orthopedic Trocar and Cannula Recalled for Sterilization Failure
Zavation's 11G Diamond Trocar/Cannula, used in orthopedic and spinal procedures, may not have been adequately sterilized. The manufacturer is recalling affected units distributed nationwide.
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 of surgical instruments with a documented sterilization failure—a serious manufacturing defect. Although no illnesses or injuries have been reported, inadequate sterilization of devices used in invasive procedures poses a significant risk of infection. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Zavation is recalling 11G Diamond Trocar/Cannula devices distributed as sterile that may not have been adequately sterilized. These surgical instruments are used in orthopedic and spinal procedures.
Inadequate sterilization of surgical instruments used in invasive procedures poses a risk of infection. While no illnesses or injuries have been reported at this time, the sterilization failure represents a significant manufacturing defect.
Healthcare facilities and surgical centers that have received these devices should cease use and contact Zavation. Patients who have undergone procedures using potentially affected instruments should consult their healthcare provider if they experience signs of infection or other complications.
The recalled product
- Product
- 11G DIAMOND 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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