Zavation Surgical Trocars Recalled Due to Sterilization Concerns
Zavation recalled 98 surgical trocars that may not be adequately sterilized. Products were distributed as sterile but may pose infection risks from inadequate sterilization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with no reported injuries or hospitalizations and a theoretical sterilization hazard warrant a High severity. Surgical instruments used in spinal procedures that may not be adequately sterilized pose an inherent risk of infection, qualifying this as a risk-of-harm product.
Plain-English summary
Zavation is recalling the ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge (REF VCF-1022-11), a surgical instrument used in orthopedic and spinal procedures. The recall involves 98 units distributed nationwide under lot numbers 20061381, 20071771, and 19123263.
The products were distributed as sterile medical devices but may not have been adequately sterilized. This sterilization failure presents a risk of infection to patients who undergo procedures using affected instruments.
Healthcare facilities and patients who may have received these instruments should consult with their healthcare providers and Zavation regarding the recall.
The recalled product
- Product
- ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 98
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 (3)
- Lot: 20061381
- 20071771
- 19123263
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.
See all 71 products in this recall →Related recalls
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