Recall Z-0052-2020— K2M, Inc
Class II · Terminated
Class II FDA medical device recall by K2M, Inc, initiated 2016-12-02, terminated 2020-05-22. It names one FDA 510(k) clearance: K171321. 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.. 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..
- Recalling firm
- K2M, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-02
- Terminated
- 2020-05-22
- Firm location
- Leesburg, VA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.