11G Direct Double Bone Access Kit May Not Be Adequately Sterilized
Zavation's 11G Direct Double Bone Access Kit for spinal and orthopedic procedures may not have been adequately sterilized during manufacturing. Distributed nationwide, the non-sterile devices may pose infection risks to patients.
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 a surgical instrument distributed as sterile but potentially not adequately sterilized. While no illnesses or injuries are reported in the source, the product represents a risk-of-harm to patients undergoing invasive procedures, meeting the rubric criterion for High severity.
Plain-English summary
The 11G Direct Double Bone Access Kit is a sterile surgical instrument used in orthopedic and spinal procedures, manufactured by Zavation. The product has been recalled because the distributed units may not have been adequately sterilized.
Adequate sterilization is critical for surgical instruments to prevent bacterial contamination and infection when used in invasive procedures. Products distributed as sterile that may not have been adequately sterilized create a potential safety risk for patients undergoing surgery.
The product was distributed nationwide throughout the United States. Healthcare facilities and surgical centers that have received or used this device should review their inventory and take appropriate action.
Patients who underwent procedures using this device should consult their healthcare provider if they have concerns or develop signs of infection. Healthcare providers should follow FDA guidance on patient notification and proper handling of affected devices.
The recalled product
- Product
- 11G DIRECT DOUBLE BONE ACCESS KIT. 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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