Orthopedic Spinal Surgery Kit Recalled for Inadequate Sterilization
Zavation is recalling InterV CurvePlus surgical kits because products distributed as sterile may not have been adequately sterilized. 36 units were 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 FDA Class II recall involves a risk-of-harm surgical device (sterilization failure) where no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury are classified as High (3).
Plain-English summary
Zavation is recalling the InterV CurvePlus Kit (REF numbers INTVMC-15-FLDSK and INTVMC-20-FLDSK), sterile surgical instruments used in orthopedic and spinal procedures. A total of 36 units were distributed nationwide.
The company determined that products distributed as sterile may not have been adequately sterilized. This creates a potential risk of infection if these instruments are used in surgical procedures without proper sterilization verification.
Affected lot numbers are: INTVMC-15-FLDSK Lot 10659ZV and INTVMC-20-FLDSK Lots 10312ZV, 11698ZV, 10276ZV, 10205ZV, and 10031ZV. Healthcare facilities should verify their inventory against these lot numbers and contact Zavation for return or replacement instructions.
The recalled product
- Product
- InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. 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 (7)
- a) INTVMC-15-FLDSK
- Lot Numbers: 10659ZV b) INTVMC-20-FLDSK
- Lot Numbers: 10312ZV
- 11698ZV
- 10276ZV
- 10205ZV
- 10031ZV
Distribution
Distributed nationwide across the United States.
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