Z-1307-2022Class II

Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal...

Name: Z-1307-2022 Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal...
Creator: K2M, Inc.
Published: 2022-06-13
License: https://open.fda.gov/license/

K2M, Inc / initiated 2022-06-13 / Open, Classified

FDA source

K2M, Inc. began a recall of Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments on 2022-06-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1307-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-13
Posted: 2022-06-30
Recalling firm: K2M, Inc
Product: Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
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 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 in commerce: 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.
Product codes and lots: UDI-DI: 10888857326804 Lot PCMW

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1307-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1307-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-30

Product code KWP

K171444Class IIYUKON OCT Spinal SystemK2m, Inc. / cleared 2017-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)