Cement Delivery Cannula May Not Be Adequately Sterilized
Zavation is recalling 10 gauge cement delivery cannulas (INTVM-CDC) used in orthopedic procedures because distributed products may not have been adequately sterilized. The recall affects 130 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 a Class II recall of a surgical device used in invasive orthopedic procedures. Although no illnesses or injuries have been reported, inadequate sterilization of devices used in surgical applications poses a direct infection risk to vulnerable patients. This constitutes a high-risk product with potential for serious harm.
Plain-English summary
Zavation is recalling 10 gauge cement delivery cannulas (model INTVM-CDC) used in orthopedic and spinal procedures. The recall involves approximately 130 units distributed nationwide across batches 19112827 and 2002440.
The products were distributed as sterile medical devices, but may not have been adequately sterilized. Non-sterile surgical devices used in invasive orthopedic and spinal procedures pose a risk of infection to patients.
Healthcare facilities and providers with affected units should identify them by batch number and contact Zavation. Patients who have undergone procedures using affected cannulas should consult their healthcare provider if they develop signs of infection or have concerns about the device used in their procedure.
The recalled product
- Product
- 10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 130
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 (2)
- product batch: 19112827
- 2002440
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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