Zavation ZVplasty Orthopedic System Recalled for Inadequate Sterilization
Zavation's ZVplasty System surgical devices may not have been adequately sterilized, creating infection risk. The recall affects 195 units distributed nationwide in the US across multiple lot numbers.
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 product (surgical device with sterilization failure used in invasive spinal/orthopedic procedures) where no illnesses or injuries have been reported. The FDA classified it as Class II, and the hazard is potential rather than confirmed. Per the rubric, products with theoretical hazards and no reported illness score at most 3 (High).
Plain-English summary
Zavation is recalling the ZVplasty System, 15mm surgical devices used in orthopedic and spinal procedures (Part Numbers VCF-1015-2 and VCF-1015-2A). The affected devices were distributed as sterile products but may not have been adequately sterilized.
Inadequate sterilization of surgical instruments poses a risk of infection when used in orthopedic and spinal procedures. The devices are manufactured by Zavation and were distributed as sterile medical devices intended for surgical use.
This recall affects 195 units distributed nationwide in the United States. Specific lot numbers have been identified for both part numbers: VCF-1015-2 (lots 13814ZV, 10950ZV, 11694ZV, 10953ZV, 10779ZV, 10588ZV, 13664ZV, 13469ZV, 13519ZV, 10825ZV, 13885ZV, 12989ZV, 10933ZV, 13758ZV, 14107ZV, 14206ZV, 14680ZV, 14022ZV, 11603ZV, 10505ZV) and VCF-1015-2A (lots 10515ZV, 14197ZV, 14114ZV, 14113ZV, 14024ZV, 14023ZV, 13641ZV, 13471ZV, 13325ZV).
Patients and healthcare providers in possession of these devices should contact Zavation or their healthcare provider for guidance on device return, destruction, or replacement to ensure proper sterilization standards are met.
The recalled product
- Product
- ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- 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 (20)
- a) VCF-1015-2
- Lot Numbers: 13814ZV
- 10950ZV
- 11694ZV
- 10953ZV
- 10779ZV
- 10588ZV
- 13664ZV
- 13469ZV
- 13519ZV
- 10825ZV
- 13885ZV
- 12989ZV
- 10933ZV
- 13758ZV
- 14107ZV
- 14206ZV
- 14680ZV
- 14022ZV
- 11603ZV
Distribution
Distributed nationwide across the United States.
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