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.
FDA Recall Z-0052-2020 · Posted None
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Recalling FirmK2M, Inc
Recall StatusTerminated
Product CodeOLO
Date Initiated2016-12-02
Date Terminated2020-05-22
Product Quantity503
Reason for Recall
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.
Firm Action
K2M notified customers with a Recall Notification Letter dated December 2, 2016. The letter instructed customers to locate and segregate recalled product, complete a tracking/verification form, and return the product to K2M.
The product was reintroduced to the market after K2M obtained new 510(k) clearance for the product.
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Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution in the states of AL CA CO CT FL FL IL IN KS MA MI MN PA TN TX UT VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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