CLASS II ONGOING Device recall · Reported 6 Jul 2022 · FDA Enforcement Report

Yukon Straight Rod recalled by K2M

K2M is recalling Yukon Straight Rod 4.0, distributed in Florida, Georgia, Nebraska, Nevada, New York, South Carolina. The recall was initiated on 13 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10888857326804 Lot PCMW

Quantity recalled53 devices (19 US; 34 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1307-2022
FDA event ID: 90462
Recalling firm: K2M, Leesburg, VA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Jun 2022
FDA classified: 30 Jun 2022
Reported: 6 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

13 Jun 2022	Recall initiated by company
30 Jun 2022	Classified by FDA	+17 days
6 Jul 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.

Florida Georgia Nebraska Nevada New York South Carolina

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 10888857326804 Lot PCMW

Where was it sold?

Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Spinal Implants recalls

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Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: Spinal CDS recalled	Medline Industries	Packaging Defects	Nationwide
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30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
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9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide