ZVplasty Direct Access Bevel Tip Trocar Recalled Due to Inadequate Sterilization
Zavation is recalling ZVplasty Direct Access Bevel Tip Trocars used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. The recall affects 98 units distributed nationwide.
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: This is an FDA Class II recall of surgical instruments with inadequate sterilization. No illnesses, injuries, or adverse events are reported in the source text. Per the rubric, a risk-of-harm product without documented harm warrants a score of 3 (High).
Plain-English summary
Zavation is recalling ZVplasty Direct Access Bevel Tip Trocars (Model REF VCF-1022-11, 11 Gauge) due to concerns about sterilization. These instruments are intended for use in orthopedic and spinal procedures. A total of 98 units have been distributed nationwide. The recalled products are from lot numbers 19123263, 20061381, and 20071771.
The company reports that products distributed as sterile may not have been adequately sterilized. Because these are surgical instruments used in invasive procedures, inadequate sterilization poses a potential risk of infection.
Healthcare facilities and practitioners who received affected units should refrain from using them. Patients treated with these instruments should contact their healthcare provider if they develop symptoms consistent with infection.
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: 19123263
- 20061381
- 20071771
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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