The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1631-2021·Announced 2021-05-26

BPB medica CEMIX Cement Mixing System Recalled for Sterility Concerns

Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX cement mixing system 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. According to the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the failure of a sterile medical device to be sterilized poses a significant risk of infection, aligning with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX, product number KVTMIXN, a vertebroplasty-kyphoplasty cement mixing system. The recall was initiated because the products were labeled as sterile but may not have been sterilized.

The affected units are identified by batch number 19123253. These products were distributed nationwide in the United States, specifically in the states of Mississippi and Kentucky.

Healthcare providers and facilities that have received these units should stop using them immediately and contact the recalling firm for instructions on return or disposal. Patients who have already received treatment with these devices should contact their healthcare provider for further guidance.

The recalled product

Product
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Manufacturer
BIOPSYBELL S.R.L.
Category
Medical Device — Surgical/Interventional
Hazard
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: 19123253

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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 →

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