Zavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization
Zavation is recalling 10G Double Cement Delivery Kits used in orthopedic and spinal procedures due to potential inadequate sterilization, creating a risk of surgical site infection.
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: The source reports no illnesses, injuries, or deaths. The product is an FDA Class II medical device with an identified sterilization defect creating a theoretical infection risk in surgical applications. This meets the criterion for score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Zavation is recalling 10G Double Cement Delivery Kits (8 fillers), medical devices used in orthopedic and spinal surgical procedures. The kits were distributed as sterile products.
According to the FDA, the distributed products may not have been adequately sterilized. Inadequate sterilization of surgical devices presents a potential risk of infection at surgical sites.
The products have been distributed nationwide across the United States. Lot numbers and distribution timeframes are pending.
The recalled product
- Product
- 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). 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.
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