ZVplasty System spinal implant recalled due to inadequate sterilization
Zavation is recalling ZVplasty System 15mm orthopedic spinal implants because products distributed as sterile may not have been adequately sterilized. Affected lot numbers were distributed nationwide.
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 Class II FDA recall of a high-risk orthopedic spinal implant with a real sterility defect that poses a risk of serious infection. The rubric classifies risk-of-harm products where injury has not yet been reported as Score 3 (High); no illnesses or injuries are mentioned in the source.
Plain-English summary
Zavation is recalling ZVplasty System 15mm, Part# VCF-1015-1, an orthopedic medical device used in spinal procedures.
The device was distributed as sterile; however, some units may not have been adequately sterilized during manufacturing. This creates a risk of infection if non-sterile devices are implanted.
The affected lot numbers include 13378ZV, 11141ZV, 10815ZV, 13971ZV, 13921ZV, 13577ZV, 13133ZV, 13033ZV, 11793ZV, 11695ZV, 12132ZV, 14105ZV, 12280ZV, 14389ZV, 13884ZV, 11956ZV, 11470ZV, 11342ZV, 10902ZV, 10516ZV, 14358ZV, 12266ZV, 10866ZV, 10651ZV, 14207ZV, 14021ZV, 11231ZV, 11465ZV, 12025ZV, 11537ZV, 11415ZV, 10998ZV, 11072ZV, and 13883ZV. These products were distributed nationwide in the United States.
Patients and healthcare providers should check with Zavation or their distributor regarding whether their implanted or in-stock devices are affected by this recall and follow the manufacturer's instructions for managing any recalled devices.
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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