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Volition™ Plating System

ORTHO SOLUTIONS HOLDINGS LIMITED · Model OS722116-NS · UDI-DI 05055662963182

LYT
1
510(k) clearances
31
Adverse events (1 deaths)
4
Recalls
7
Facilities

Description

OLIVE WIRE, 2.0 X 70MM, 1.6 X 12MM THREADED TROCAR TIP

Recalls

DateFirmReason
2018-06-21Ossur AmericasHalo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium
2008-09-26OssurOssur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
2008-09-26OssurOssur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
2008-09-26OssurOssur 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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Data 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.