K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of 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 a type of spinal spacer used in surgery because it can break during procedures, potentially causing complications. This affects specific models with catalog number 5203-90115 and lot number FKXA.
The spacer is made of two welded pieces that can break during surgery, causing the tip to detach. This may lead to complications if the broken piece remains in the patient or causes injury during the procedure.
Surgical patients and medical professionals using K2M's Aleutian Anatomically Narrow Lordotic Spreader systems for spinal procedures. Those with the specific catalog number 5203-90115 and lot number FKXA are most at risk.
Check for the catalog number 5203-90115 and lot number FKXA on the product label. This spacer is used in spinal procedures to simulate cage height and expand disc space.
Look for catalog number 5203-90115 and lot number FKXA on the spacer's label.
The recall states the spacer can break during procedures, so it is not safe to use without checking the recall status.
The recall does not specify a remedy, so check with K2M directly for guidance.
Look for catalog number 5203-90115 and lot number FKXA 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-2012-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2012-2020 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.
