Biopsybell Cement Mixing System Recalled for Potential Sterility Failure
Biopsybell S.R.L. is recalling 500 units of the Cement Mixing System, Vertebroplasty-Kyphoplasty, Ref VCF-1051, because products labeled as sterile 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Under the severity rubric, an FDA Class II recall involving a medical device where the failure of a critical safety feature (sterility) poses a significant risk of harm is classified as Severe.
Plain-English summary
Biopsybell S.R.L. is recalling 500 units of the Cement Mixing System, Vertebroplasty-Kyphoplasty, Ref VCF-1051. The recall is due to a potential failure in the sterilization process, meaning that products labeled as sterile may not have been sterilized.
The affected units are identified by Batch 2003721. These products were distributed nationwide in the United States, specifically within the states of Mississippi and Kentucky.
Healthcare providers and facilities that have received this product should stop using it immediately and contact Biopsybell S.R.L. for further instructions on how to return or dispose of the units.
The recalled product
- Product
- CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 500
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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