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BIOPSYBELL
BIOPSYBELL SRL · Model RENOVA SPINE BONE FILLER · UDI-DI 08033860024550
OAR
Prescription
1
510(k) clearances
188
Adverse events (1 deaths)
26
Recalls
70
Facilities
Description
KYPHOPLASTY BONE FILLER KIT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| 2024-06-03 | Stryker Corporation | Expired Products distributed to customers |
| 2020-02-13 | Merit Medical Systems, Inc. | Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five |
| 2020-02-13 | Merit Medical Systems, Inc. | Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five |
| 2017-12-06 | Medtronic Sofamor Danek USA Inc | Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument. |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-05-17 | Medtronic Sofamor Danek USA Inc | The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may |
| 2013-07-30 | Synthes USA HQ, Inc. | Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device. |
| 2012-11-10 | Orthovita, Inc., dBA Stryker Orthobiologics. | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bend |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.