InterV Kyphoplasty Spinal Devices Recalled for Inadequate Sterilization
Zavation's InterV 10G FLEX Kyphoplasty spinal devices are recalled because they may not have been adequately sterilized. The recall affects 178 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 a risk-of-harm medical device (spinal implant used in invasive procedures) where sterilization failure could lead to serious infection. Although no illnesses or injuries have been reported in the source text, the potential for significant harm from non-sterile spinal implants justifies a High severity rating.
Plain-English summary
Zavation has recalled InterV 10G FLEX Kyphoplasty devices used in orthopedic spinal procedures. The affected products have REF numbers INTVM-15-FLDSK and INTVM-20-FLDSK and were distributed throughout the United States.
The devices are being recalled because they were distributed as sterile but may not have been adequately sterilized. This poses a potential infection risk to patients who receive these devices during spinal procedures.
The recall involves 178 units across 16 specific lot numbers. Patients and healthcare providers who have received or may have received one of these devices should contact their healthcare provider or Zavation for guidance.
The recalled product
- Product
- InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Category
- Medical Device — Spinal Implant
- 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 (17)
- a) INTVM-15-FLDSK
- Lot Numbers:10342ZV
- 12525ZV
- 12267ZV
- 12011ZV
- 10545ZV
- 10048ZV
- 11861ZV
- 11343ZV
- 11037ZV
- 10780ZV
- 11102ZV b) INTVM-20-FLDSK
- Lot Numbers: 10312ZV
- 11698ZV
- 10276ZV
- 10205ZV
- 10031ZV
Distribution
Distributed nationwide across the United States.
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