InterV 11G Kyphoplasty Kit Recall: Sterilization Defect May Increase Infection Risk
Zavation is recalling 119 InterV 11G Kyphoplasty Kits distributed nationwide because they may not have been adequately sterilized, which could increase the risk of infection during spinal surgery.
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 FDA Class II recall involves a sterile medical device used in spinal surgery that may not have been adequately sterilized. Although no illnesses or injuries have been reported, the hazard creates a significant risk of harm, qualifying it as high-severity.
Plain-English summary
Zavation is recalling 119 InterV 11G Kyphoplasty Kits used in orthopedic and spinal procedures. The recall covers units with the following Reference numbers: INTVMN-10-DSK, INTVMN-15-DSK, INTVMN-15-DSKC, and INTVMN-20-DSK distributed nationwide.
The recalled kits were released as sterile medical devices but may not have been adequately sterilized. This creates a risk of microbial contamination that could cause infection during spinal surgery procedures.
Healthcare providers who have received these kits should check the lot numbers in their inventory against the recall information. Patients who underwent spinal surgery and believe they may have been affected should contact their healthcare provider.
The recalled product
- Product
- InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 119
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 (16)
- a) INTVMN-10-DSK
- Lot Numbers: 12200ZV b) INTVMN-15-DSK
- Lot Numbers: 10816ZV
- 13708ZV
- 13845ZV
- 13522ZV
- 12133ZV c) INTVMN-15-DSKC
- Lot Numbers: 11843ZV
- 11412ZV
- 11160ZV
- 11017ZV d) INTVMN-20-DSK
- Lot Numbers: 14266ZV
- 14238ZV
- 12524ZV
- 11756ZV
- 11083ZV
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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