Biopsybell CEMIX Cement Mixing System Recalled for Sterility Concerns
Biopsybell S.R.L. is recalling CEMIX Cement Mixing Systems labeled as sterile because they 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, and the hazard involves a failure of sterility in a medical device, which carries a significant risk of serious injury or infection.
Plain-English summary
Biopsybell S.R.L. is recalling 1,000 units of the CEMIX Cement Mixing System (Code INTV-MMS) under FDA recall number Z-1642-2021. The affected products were distributed in the United States, specifically in the states of Mississippi and Kentucky.
The recall was initiated because the products were labeled as sterile but may not have been sterilized. This defect presents a potential risk of infection or other adverse health consequences if the unsterilized devices are used in clinical settings.
Consumers and healthcare facilities should stop using the affected CEMIX Cement Mixing Systems immediately. Affected lots include 2001185, 2001243, and 20051163. Users should contact Biopsybell S.R.L. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 1,000
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 (3)
- LOT: 2001185
- 2001243
- 20051163
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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