FDA Enforcement
Class II
Terminated
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.
Recall: Z-0052-2020
·
Reported October 16, 2019
Enforcement
- Recall Number
- Z-0052-2020
- Event ID
- 83777
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- K2M, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 16, 2019
- Initiation Date
- December 2, 2016
- Classification Date
- October 7, 2019
- Termination Date
- May 22, 2020
- Address
- 600 Hope Pkwy SE, N/A, Leesburg, VA, 20175-4428, United States
Description
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.
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 Info
All product lots in distribution as of December 1, 2016, are in scope.
Distribution
US Nationwide Distribution in the states of AL CA CO CT FL FL IL IN KS MA MI MN PA TN TX UT VA
Quantity
503