Device 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.
Z-0052-2020
Product summary
- Firm
- K2M, Inc
- Event
- Event 83777
- Status
- Terminated
- Classification
- Class II
- Quantity
- 503
- Official record key
device-enforcement:Z-0052-2020
Official wording
Reason: 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.
Code information: All product lots in distribution as of December 1, 2016, are in scope.
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
Derived failure modes
-
Unknown
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.