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MEDTRONIC SOFAMOR DANEK, INC. · Model EX07101308 · UDI-DI 00613994853592
HTR
Prescription
9
510(k) clearances
281
Adverse events (1 deaths)
2
Recalls
265
Facilities
Description
RASP EX07101308 MED 14MM 12 DEG
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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