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Blustone Synergy Cervical Rasp
BLUSTONE SYNERGY, LLC · Model 9014-CRL8 · UDI-DI 00810482030873
HTR
Prescription
9
510(k) clearances
285
Adverse events (1 deaths)
2
Recalls
265
Facilities
Description
The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical rasps are available in parallel and lordotic configurations, 14mmX11mm and 17mmX13mm sizes and thicknesses between 5mm and 11mm.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2008-08-08 | Sterilmed Inc | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e |
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