FDASeptember 25, 2015device
Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device.
What to do
FDA enforcement status: Terminated
Brands named
stryker spinestryker
Recall history
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