Zavation ZVplasty Direct Access Beveled Tip Surgical Trocars Recalled for Inadequate Sterilization
Zavation is recalling 335 units of ZVplasty Direct Access Beveled Tip Trocars (10 Gauge) used in orthopedic and spinal procedures because affected units may not have been adequately sterilized.
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: FDA Class II medical device recall. Inadequate sterilization of surgical instruments used in invasive procedures poses a significant infection risk. No illnesses or injuries are reported in the source, limiting the score to High (3) per rubric guidelines.
Plain-English summary
Zavation Medical Technologies is recalling 335 units of the ZVplasty Direct Access Beveled Tip Trocar (10 Gauge, REF VCF-1022), a surgical instrument used in orthopedic and spinal procedures. The affected devices are identified by lot numbers 20071558, 19113038, 20102491, and 20041108.
The recalled products were distributed as sterile but may not have been adequately sterilized. Inadequate sterilization of surgical instruments used in invasive procedures creates a risk of infection.
The affected devices were distributed nationwide in the United States.
The recalled product
- Product
- ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Hazard
- Affected units
- 335
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 (4)
- Lot: 20071558
- 19113038
- 20102491
- 20041108
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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