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Halo Systems
OSSUR AMERICAS, INC. · Model 517DS · UDI-DI 05690977192577
LYT
Prescription
1
510(k) clearances
31
Adverse events (1 deaths)
4
Recalls
7
Facilities
Description
Skull Pin 3in CT Sterl 4 PK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-21 | Ossur Americas | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium |
| 2008-09-26 | Ossur | Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products. |
| 2008-09-26 | Ossur | Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products. |
| 2008-09-26 | Ossur | Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products. |
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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.