Orthopedic Cement Delivery Kits Recalled Due to Sterilization Concerns
Zavation's 10G cement delivery kits for spinal procedures may not be adequately sterilized despite being marketed as sterile. Patients and healthcare providers should contact Zavation regarding potentially affected units.
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 FDA recall of a sterile medical device with potential infection risk. No illnesses or injuries have been reported. The hazard is theoretical but serious for orthopedic/spinal surgery, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zavation is recalling its 10G Single Cement Delivery Kit (5 Fillers) used in orthopedic and spinal surgical procedures. The products were distributed as sterile but may not have been adequately sterilized during manufacturing.
Patients who have undergone orthopedic or spinal procedures involving these cement kits should be aware of this sterilization issue. Healthcare facilities in the United States that have received these products should stop using them immediately.
Patients concerned about procedures performed with these kits should consult their healthcare provider. Healthcare facilities should contact Zavation for information on product identification, return, and proper disposal.
The recalled product
- Product
- 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Hazard
- inadequate-sterilization
- 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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