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 could lead to complications for patients needing spinal surgery.
The spreader tip can break during spinal procedures, potentially causing complications for patients. This happens because the two pieces are welded together and may separate under stress during surgery.
Patients undergoing spinal surgery who use this specific interbody spacer system are affected. Surgeons and medical facilities that have the recalled model are most at risk.
Check for catalog number 5203-90167 and lot number FKXT on the product. The product is a stainless steel, non-sterile spacer used in spinal procedures.
Look for catalog number 5203-90167 and lot number FKXT on the product label.
The recall indicates a risk of spreader tip breaking during surgery, so it is not recommended for use until the recall is addressed.
The recall does not specify a remedy, so contact K2M directly for guidance.
Check for catalog number 5203-90167 and lot number FKXT 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-2027-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2027-2020 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.
