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K2M, Inc recalls K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Con
Recalled October 16, 2019 · FDA recall Z-0052-2020 · K2M
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. · FDA Class II
Units
503
Sold at
US Nationwide Distribution in the states of AL CA CO CT FL FL IL IN KS MA MI MN PA TN TX UT VA
Description
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.
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.
Manufacturer(s)
K2M, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →