Biopsybell Recalls Sterile Spine Bone Filler Due to Sterilization Concerns
Biopsybell S.R.L. is recalling 60 units of Renova Spine Bone Filler labeled as sterile but potentially not sterilized. The product was distributed in Mississippi and Kentucky.
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 labeled as sterile that may not have been sterilized, posing a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biopsybell S.R.L. is recalling 60 units of Renova Spine Bone Filler 10G 12CM Centim. Sterile, model RESFIL1112C1-US. The recall is due to a concern that products labeled as sterile may not have been sterilized.
The affected product is identified by Batch 20061305. It was distributed nationwide in the United States, specifically in the states of Mississippi and Kentucky.
Consumers and healthcare providers should stop using the product and contact Biopsybell S.R.L. for further instructions or a return.
The recalled product
- Product
- RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 60
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: 20061305
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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