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 Anatomically Narrow Lordotic Spreader systems because the spreader tip can break off during spinal procedures. This poses a risk of complications during surgery that could affect patient safety.
The spreader tip can break off during spinal procedures, potentially causing complications. This breakage could lead to unintended movement of surgical instruments or damage to surrounding tissues during the procedure.
Surgical teams using the recalled Aleutian Anatomically Narrow Lordotic Spreader systems for spinal procedures are most at risk. Patients undergoing these procedures with the affected models may also be impacted.
Check for catalog number 5203-90181 and lot number FKXX on the product. The product is a stainless steel, non-sterile interbody spacer system used for spinal procedures.
Verify the catalog number (5203-90181) and lot number (FKXX) 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 the product details to confirm if it is affected and contact K2M for further instructions.
The recall indicates a risk of spreader tip breaking off during procedures, so it is not recommended for use until the manufacturer provides a remedy.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2031-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2031-2020 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.
