K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal procedures. Affected units have specific catalog and lot numbers.
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
K2M is recalling Aleutian Anatomically Narrow Lordotic Spreader systems because the spreader tip can break during spinal procedures. This poses a risk of complications during surgery that could affect patient safety.
The spreader tip can break during spinal procedures, potentially causing complications for patients. This occurs because the device is manufactured as two pieces welded together, which has been associated with the tip breaking off during surgery.
Surgical teams using the Aleutian Anatomically Narrow Lordotic Spreader for spinal procedures are affected. Patients undergoing spinal surgery with this device are at risk of complications if the spreader tip breaks during the procedure.
Check for catalog number 5203-90163 and lot number FKXP on the device. The product is a stainless steel, non-sterile interbody spacer system used in spinal procedures.
Look for catalog number 5203-90163 and lot number FKXP on the device.
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together, which has been associated with the spreader tip breaking off during spinal procedures.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected product.
The recall indicates a risk of the spreader tip breaking during procedures, so it is not safe to use without checking the recall status.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2025-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2025-2020 from K2M. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
