ZVplasty Orthopedic Spinal System Units Recalled Due to Inadequate Sterilization
Zavation is recalling 516 units of ZVplasty System (15mm) spinal surgical devices because products distributed as sterile may not have been adequately sterilized. Patients who received this device may face infection risk.
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 an FDA Class II medical device recall. While no illnesses or injuries have been reported, inadequate sterilization of surgical implants used in spinal procedures represents a significant risk of infection. The hazard meets the criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zavation is recalling 516 units of the ZVplasty System, 15mm (Part# VCF-1015-1), used in orthopedic and spinal surgical procedures. The recall affects 34 specific lot numbers and applies to all units distributed nationwide throughout the United States.
The devices were distributed to medical facilities with the representation that they were sterile. However, products in this recall may not have been adequately sterilized prior to distribution. This sterilization failure could allow bacterial contamination and poses an infection risk to patients.
This recall affects any patient who received care using one of the recalled lot numbers and healthcare facilities that stock affected units. Surgeons and facility staff should discontinue use of these devices immediately.
If you or someone you know received care involving this device, consult your healthcare provider. Healthcare facilities should verify lot numbers against the FDA recall notice and remove affected units from surgical inventory.
The recalled product
- Product
- ZVplasty System, 15mm, Part# VCF-1015-1. 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)
- Lot Numbers: 13378ZV
- 11141ZV
- 10815ZV
- 13971ZV
- 13921ZV
- 13577ZV
- 13133ZV
- 13033ZV
- 11793ZV
- 11695ZV
- 12132ZV
- 14105ZV
- 12280ZV
- 14389ZV
- 13884ZV
- 11956ZV
- 11470ZV
- 11342ZV
- 10902ZV
- 10516ZV
Distribution
Distributed nationwide across the United States.
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