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. Contact K2M for details.
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. This breakage could lead to unintended movement of the spinal implant or other surgical issues.
Surgical teams using the Aleutian Anatomically Narrow Lordotic Spreader for spinal procedures are most at risk. Patients scheduled for spinal surgery with this specific product may be affected.
Check for catalog number 5203-90121 and lot number FKXB on the product. The product is a stainless steel, non-sterile interbody spacer system used for spinal procedures.
Look for catalog number 5203-90121 and lot number FKXB on the product label.
The recall indicates a risk of spreader tip breaking during procedures, so it is not recommended for use until the remedy is addressed.
The recall record does not specify a remedy, so contact K2M directly for guidance.
Check for catalog number 5203-90121 and lot number FKXB on the product label.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2013-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2013-2020 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.
