FDADecember 2, 2016device
K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their standard surgical technique.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Instruments were developed without adequate consideration given to the need for a new regulatory filing. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; recall actions were completed in 2017.
What to do
FDA enforcement status: Terminated
Brands named
k2m
Recall history
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