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All product recalls associated with Blackstone Medical, Inc..
Total Recalls
4
Past Year
0
Class I (Serious)
0
Most Recent
May 2009
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Product marketed without an approved 510(k)
Manufacturing Defect: The saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. The extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. As a consequence, there is a potential for set-screw cross-threading during implantation. Cross-threading could in turn lead to a comprom
Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification