Biopsybell Easynject Device Recalled for Potential Sterility Failure
Biopsybell is recalling five Easynject vertebroplasty devices because they were labeled sterile but may not have been sterilized.
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: The recall involves a medical device that may not be sterile, posing a risk of infection or harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Biopsybell S.R.L. is recalling five units of the Easynject device, reference KVTGUN-DS, used for cement infusion in the vertebroplasty procedure. The recall is due to a potential failure in the sterilization process.
The affected devices were labeled as sterile, but the manufacturer indicates they may not have been sterilized. The specific batch number is 2003721. These units were distributed nationwide in the United States, specifically in the states of Mississippi and Kentucky.
Healthcare facilities and consumers who have these devices should stop using them immediately. Users should contact Biopsybell S.R.L. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 5
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 (1)
- BATCH:2003721
Distribution
Part of a larger recall action
This product is one of 19 recalled by BIOPSYBELL S.R.L. 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 19 products in this recall →Related recalls
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