Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
FDA Recall Z-1307-2022 · Posted None
Recalling FirmK2M, Inc.
Recall StatusOpen, Classified
Product CodeKWP
Date Initiated2022-06-13
Product Quantity53 devices (19 US; 34 OUS)
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.
Firm Action
On 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.
Root Cause
Under Investigation by firm
Distribution Pattern
Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.