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
- Recall Number
- Z-0052-2020
- Event Number
- 83777
- FEI Number
- 3008599177
- Product Code
- OLO
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 2, 2016
- Terminated
- May 22, 2020
- Address
- K2M Inc 600 Hope Pkwy SE, Leesburg, VA, 20175-4428
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.
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.
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. for question call at 571-919-2000
US Nationwide Distribution in the states of AL CA CO CT FL FL IL IN KS MA MI MN PA TN TX UT VA
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