Recall Z-0052-2020
K2M, Inc · initiated December 2, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All product lots in distribution as of December 1, 2016, are in scope.
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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
Details
- Recall number
- Z-0052-2020
- Initiated
- December 2, 2016
- Terminated
- May 22, 2020
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Quantity
- 503
- 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
- Recalling firm
- K2M, Inc, Leesburg, VA