K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking off 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 certain Aleutian Interbody Spacer Systems because the spreader tip can break off during spinal procedures. This could lead to complications for patients needing spinal surgery.
The spreader tip can break off during spinal procedures, potentially causing complications for patients. This occurs because the two pieces were welded together without proper strength.
Patients undergoing spinal surgery who use the recalled Aleutian Anatomically Narrow Lordotic Spreader systems are affected. Medical professionals using these specific models during procedures are at highest risk.
Check for catalog number 5203-90155 and lot number FKXM on the product. The product is a stainless steel, non-sterile interbody spacer system used in spinal procedures.
Look for catalog number 5203-90155 and lot number FKXM on the product label.
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.
The recall record does not specify a remedy, so check with K2M directly for guidance.
The recall indicates the spreader tip can break off during procedures, which could lead to complications, but the record does not specify the severity of injury.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2023-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2023-2020 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.
