Orthopedic bone access kits recalled for inadequate sterilization
Zavation recalled its 10G Direct Double Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. Affected devices are used in orthopedic and spinal procedures.
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 FDA classified this as a Class II medical device recall. Inadequate sterilization of surgical instruments poses a potential infection risk to patients, but no illnesses have been reported. This fits the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Zavation has recalled the 10G Direct Double Bone Access Kit, a medical device used in orthopedic and spinal procedures. According to the recall notice, some units that were distributed as sterile may not have been adequately sterilized.
Surgical devices that have not been properly sterilized could potentially expose patients to infection. These devices have been distributed nationwide throughout the United States.
Patients who have had procedures using this device should contact their healthcare provider with any concerns related to their procedure or recovery.
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.
See all 71 products in this recall →Related recalls
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