BIOPSYBELL CEMIX Cement Mixer Recall: Sterilization Risk
BIOPSYBELL recalls CEMIX vertebroplasty cement mixers due to potential unsterilized products. Affected units may pose infection risks if used without proper sterilization.
Lower-risk recall
Products labeled as sterile were distributed, but may not have been sterilized.
Contact the company
What happened, in plain English
BIOPSYB: The company recalls its CEMIX cement mixing system for vertebroplasty and kyphoplasty procedures because some units may not have been properly sterilized. Using these products could lead to infections if they are not sterile. Read more at govinfonow.com/recall/62997-biopsybell-cemix-cement-mixer-recall-sterilization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62997-biopsybell-cemix-cement-mixer-recall-sterilization-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1631-2021
Cite this page
“BIOPSYBELL CEMIX Cement Mixer Recall: Sterilization Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62997-biopsybell-cemix-cement-mixer-recall-sterilization-risk. Based on FDA recall #Z-1631-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1631-2021%22&limit=1).
Why it’s dangerous
The recall states that products labeled as sterile may not have been sterilized during manufacturing. This could lead to infections if the equipment is used without proper sterilization.
Who’s affected
Medical professionals using the CEMIX system for spinal procedures are most at risk. Patients undergoing these treatments may be affected if the equipment is not properly sterilized.
How to tell if you have this one
Check for the product number KVTMIXN on the CEMIX system. The batch number 19123253 is associated with the affected units.
- Brand
BIOPSYBELL- Category
Medical device
All 19 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide distribution in the states MS and KY.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1631-2021 | BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system; BATCH: 19123253 | 5 units |
| Z-1632-2021 | RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US; BATCH: 20061305 | 60 units |
| Z-1633-2021 | BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US; BATCH: 20061307 | 10 units |
| Z-1634-2021 | BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111; BATCH Numbers: 20061439 | 50 units |
| Z-1635-2021 | CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051; BATCH:2003721 | 500 units |
| Z-1636-2021 | EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS; BATCH:2003721 | 5 units |
| Z-1637-2021 | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD; LOT: 19102741, 200127, 2001246, 2101242 | 625 units |
| Z-1638-2021 | 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC; LOT: 19112827, 2002440 | 250 units |
| Z-1639-2021 | 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK; LOT: 2001201, 2003859, 20051288, 20061419 | 330 units |
| Z-1640-2021 | 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB; LOT: 20061432 | 30 units |
| Z-1641-2021 | 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK; LOT: 2001185, 2001243, 20051163 | 160 units |
| Z-1642-2021 | CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS; LOT: 2001185, 2001243, 20051163 | 1000 units |
| Z-1643-2021 | 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD; LOT: 2002437 | 75 units |
| Z-1644-2021 | 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK; LOT: 20051162 | 50 units |
| Z-1645-2021 | 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB; LOT: 30061432 | 30 units |
| Z-1646-2021 | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK; LOT: 2002439, 20051290, 20061420, 20081943 | 305 units |
| Z-1647-2021 | 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15; LOT: 20071561 | 50 units |
| Z-1648-2021 | 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC; LOT: 20102495 | 40 units |
| Z-1649-2021 | 10 GAUGE DRILL, CODE INTVM-DRL; LOT: 20102486 | 75 units |
What to do — step by step
Check Sterilization Status
Verify if the unit was sterilized by checking the product label for the batch number 19123253.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states MS and KY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Kentucky, Mississippi.
Recall timeline
FDA terminated this recall 4.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1631-2021 (March 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1631-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.