Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
K2M Special Connector Instruments (Special Connector Recalled by K2M, Inc Due to Instruments were developed without adequate consideration given to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact K2M, Inc directly.
Affected Products
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.
Quantity: 503
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About K2M, Inc
K2M, Inc has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report