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.
What this means for you
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
- Hazard
- sterilization-failure
- infection-risk
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.
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