medical Class II Updated 2019-10-16

K2M, Inc recalls K2M Special Connector Instruments (Special Connector, Specia

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All product lots in distribution as of December 1, 2016, are in scope.
View official government recall

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