Zavation InterV 10G kyphoplasty kits recalled due to inadequate sterilization
Zavation is recalling InterV 10G Kyphoplasty Kits because products distributed as sterile may not have been adequately sterilized. The recall affects 503 units distributed nationwide.
What this means for you
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 with no reported illnesses or injuries. The hazard—inadequate sterilization of surgical devices—is theoretical, meeting the criterion for a risk-of-harm product with no reported injury.
Plain-English summary
Zavation is recalling InterV 10G Kyphoplasty Kits used in orthopedic and spinal procedures. The affected lot numbers are specified by reference number (INTVM-10-DSK, INTVM-10-SBK, INTVM-15-DSK, INTVM-15-DSKC, INTVM-15-SBK, INTVM-15-SIKBC, INTVM-20-DSK, and INTVM-20-SBK).
Products were distributed as sterile but may not have been adequately sterilized. Inadequate sterilization poses a risk of post-operative infection if the devices are used in patient procedures.
A total of 503 units were distributed nationwide to hospitals and surgical centers. Healthcare providers with affected lots should contact Zavation or reference the FDA recall notice for instructions.
The recalled product
- Product
- InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Hazard
- inadequate-sterilization
- infection-risk
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 (20)
- a) INTVM-10-DSK
- lot numbers:13724ZV
- 13517ZV
- 13384ZV
- 11658ZV
- 12985ZV
- 12259ZV
- 11692ZV b) INTVM-10-SBK
- lot numbers:12400ZV
- 10784ZV
- 14384ZV
- 12329ZV
- 11928ZV c) INTVM-15-DSK
- lot numbers:12885ZV
- 12108ZV
- 11294ZV
- 13761ZV
- 11071ZV
- 13908ZV
- 13846ZV
Distribution
Distributed nationwide across the United States.
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