Zavation 10G Direct Single Bone Access Kit Recall Due to Inadequate Sterilization
Zavation is recalling its 10G Direct Single Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. The kit is used in orthopedic and spinal procedures and was distributed nationwide.
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 recall of a sterile surgical device with confirmed inadequate sterilization. Although no illnesses or injuries have been reported, the product represents a risk-of-harm scenario for patients undergoing invasive orthopedic and spinal procedures, meeting the criterion for High severity.
Plain-English summary
Zavation is recalling the 10G Direct Single Bone Access Kit, a surgical instrument used in orthopedic and spinal procedures. The product was distributed nationwide in the United States.
Some products distributed as sterile may not have been adequately sterilized. Non-sterile surgical instruments used in orthopedic and spinal procedures may increase the risk of infection for patients.
The recalled product
- Product
- 10G DIRECT SINGLE 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.
See all 71 products in this recall →Related recalls
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