FDA-Device2015-10-21Class II
Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Zimmer Gmbh
Hazard
In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.
Sold states
US Nationwide distribution.
Affected count
57,603 units
Manufactured in
Sulzer Allee 8, N/A, Winterthur, N/A, Switzerland
Products
Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0119-2016Don't want to check this manually?
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