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U.S. Department of Health and Human Services

Class 2 Device Recall Yukon Straight Rod

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 Class 2 Device Recall Yukon Straight Rodsee related information
Date Initiated by FirmJune 13, 2022
Create DateJune 30, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1307-2022
Recall Event ID 90462
510(K)NumberK171444 
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
ProductYukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Code Information UDI-DI: 10888857326804 Lot PCMW
Recalling Firm/
Manufacturer		 K2M, Inc.
600 Hope Pkwy Se
Leesburg VA 20175-4428
For Additional Information ContactRegulatory Compliance
201-749-8090
Manufacturer Reason
for Recall		Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn June 13, 2022, the firm distributed Medical Device Recall letters to affected customers. Customers were informed that local Stryker Sales Representative or Stryker Branch or Agency has already removed any product still located in customer facilities at the time of the initiation of the removal. If you have any questions or concerns, please contact Regulatory Compliance at 201.749.8090.
Quantity in Commerce53 devices (19 US; 34 OUS)
DistributionDomestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KWP
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