Biopsybell 10 Gauge Cement Delivery Cannula Recalled for Sterility Concerns
Biopsybell S.R.L. is recalling 250 units of 10 Gauge Cement Delivery Cannulas labeled as sterile but potentially not sterilized.
What this means for you
Illness, injury, or structural failure has been reported. 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 medical device that may not be sterile, which carries a risk of serious injury such as infection.
Plain-English summary
Biopsybell S.R.L. is recalling 250 units of 10 Gauge Cement Delivery Cannulas, code INTVM-CDC. The recall involves specific lots identified as 19112827 and 2002440. These medical devices were distributed in the United States, specifically in the states of Mississippi and Kentucky.
The reason for the recall is that the products were labeled as sterile but may not have been sterilized. This potential failure in the sterilization process poses a risk of infection or other complications if the devices are used in patients.
Healthcare providers and facilities that received these devices should stop using them immediately and contact Biopsybell S.R.L. for instructions on return or disposal. Patients who have had these devices implanted should consult their healthcare provider for guidance on monitoring for potential complications.
The recalled product
- Product
- 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 250
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 (2)
- LOT: 19112827
- 2002440
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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