Recall Z-1751-2021— Zavation
Class II · Terminated
Class II FDA medical device recall by Zavation, initiated 2021-03-25, terminated 2023-03-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Products distributed as sterile may not have been adequately sterilized.
- Recalling firm
- Zavation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-25
- Terminated
- 2023-03-20
- Firm location
- Flowood, MS, United States
Product description
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.
Reason for recall
Products distributed as sterile may not have been adequately sterilized
Data sourced from openFDA. This site is unofficial and independent of the FDA.