Zavation 10G Direct Double Bone Access Kit May Not Be Properly Sterilized
Zavation recalled its 10G Direct Double Bone Access Kit used in orthopedic surgery because products distributed as sterile may not have been adequately sterilized, potentially exposing patients to 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: This is an FDA Class II device recall for sterilization failure on surgical instruments used in orthopedic procedures. While no illnesses or injuries have been reported, non-sterile surgical instruments present a serious risk of infection to patients, meeting the rubric criterion of risk-of-harm where injury has not yet been reported.
Plain-English summary
Zavation is recalling the 10G Direct Double Bone Access Kit, a surgical instrument kit used in orthopedic and spinal procedures that has been distributed nationwide in the United States.
The kits were distributed as sterile medical devices, but products in this recall may not have been adequately sterilized. Non-sterile surgical instruments can introduce bacteria or other contaminants during surgical procedures, creating a risk of patient infection.
Healthcare facilities that have received these kits should contact Zavation for identification of affected units and instructions for handling. Providers should secure the kits from use pending further guidance from the manufacturer and the FDA.
The recalled product
- Product
- 10G DIRECT DOUBLE BONE ACCESS KIT. 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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