Recall Z-1307-2022 ยท KWP Appliance, Fixation, Spinal Interlaminal
K2M, Inc.
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
| Date | Jun 13, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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. |
| Quantity | 53 devices (19 US; 34 OUS) |
| Distribution | Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171444 | YUKON OCT Spinal System K2m, Inc., Aug 8, 2017 |