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U.S. Department of Health and Human Services

Class 2 Device Recall DENALI, CASPIAN, EVEREST, MESA, and ALEUTIAN

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 Class 2 Device Recall DENALI, CASPIAN, EVEREST, MESA, and ALEUTIANsee related information
Date Initiated by FirmDecember 02, 2016
Create DateOctober 07, 2019
Recall Status1 Terminated 3 on May 22, 2020
Recall NumberZ-0052-2020
Recall Event ID 83777
510(K)NumberK171321 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductK2M 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.
Code Information All product lots in distribution as of December 1, 2016, are in scope.
FEI Number 3008599177
Recalling Firm/
Manufacturer		 K2M, Inc
600 Hope Pkwy SE
Leesburg VA 20175-4428
Manufacturer 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 2		Nonconforming Material/Component
ActionK2M 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
Quantity in Commerce503
DistributionUS Nationwide Distribution in the states of AL CA CO CT FL FL IL IN KS MA MI MN PA TN TX UT VA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = OLO
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