Orthopedic Bone Access Tools May Lack Proper Sterilization
Zavation is recalling InterV 10G Bone Access Tools (Lot 11613ZV) distributed nationwide because they may not have been adequately sterilized. No illnesses have been reported.
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 involving surgical instruments with a sterilization failure. No illnesses or injuries have been reported; however, inadequate sterilization of orthopedic surgical tools presents a risk of harm in the surgical setting, meeting the High (3) criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zavation is recalling the InterV 10G Bone Access Tools/Kit (reference number INTVM-FLNK) used in orthopedic and spinal procedures. The recall affects products from Lot 11613ZV that were distributed nationwide in the United States.
The products were distributed as sterile but may not have been adequately sterilized. This creates a potential risk of contamination if used in surgical procedures.
Healthcare facilities and providers that received this lot number should stop using the affected tools immediately. Contact Zavation for instructions on return or replacement of the affected lot.
The recalled product
- Product
- InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 3
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)
- Lot Numbers: 11613ZV
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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