Zavation recalls ZVplasty Diamond Tip Trocar due to sterilization failure
Zavation is recalling 113 units of ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) due to inadequate sterilization. The devices were distributed nationwide and may not be safe for use in orthopedic and spinal procedures.
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 recall of surgical instruments with inadequate sterilization. No hospitalizations or injuries have been reported, making this a risk-of-harm situation without documented injury, consistent with severity score 3 (High).
Plain-English summary
Zavation is recalling 113 units of the ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge (REF VCF-1023-11). This surgical instrument is designed for use in orthopedic and spinal procedures.
The devices were distributed as sterile but may not have been adequately sterilized. Inadequate sterilization of surgical instruments can result in infection during or after procedures.
The recall affects lot numbers 19123264 and 20071773, which were distributed nationwide in the United States.
The recalled product
- Product
- ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 113
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 (2)
- Lot: 19123264
- 20071773
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
Same manufacturer · Zavation
See all →- HighZavation 10G Direct Double Bone Access Kit May Not Be Properly Sterilized
FDA (Devices) · 2021-06-09
- HighZVplasty System spinal implant recalled due to inadequate sterilization
FDA (Devices) · 2021-06-09
- HighZVplasty orthopedic surgical devices may lack adequate sterilization
FDA (Devices) · 2021-06-09
- HighZavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization
FDA (Devices) · 2021-06-09
- HighOrthopedic bone access kits recalled for inadequate sterilization
FDA (Devices) · 2021-06-09
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateStryker Endoscopy Recalls 11mm Trocars Due to Sterilization Documentation Issues
FDA (Devices) · 2014-12-24
- HighStep Bladeless Trocars recalled for sterilization failure
FDA (Devices) · 2023-04-19
- ModerateStryker Laparoscopic Trocar Recall Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
- ModerateStryker 3.5mm Trocar Recalled for Sterilization Instructions Error
FDA (Devices) · 2014-12-24
- ModerateStryker Endoscopy Recalls 3.5mm Pyramidal Trocars Due to Sterilization Labeling Error
FDA (Devices) · 2014-12-24
- ModerateZimmer Biomet Recalls K-Wire Trochar Tips Due to Packaging Seal Issues
FDA (Devices) · 2019-07-10