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 spinal implants because the spreader tip can break during surgery. This poses a risk of complications during spinal procedures.
The spreader tip can break during spinal surgery procedures, potentially causing complications. This occurs because the implant is manufactured as two pieces welded together, which has been associated with the tip breaking off during use.
Surgical patients and medical professionals using K2M's Aleutian Anatomically Narrow Lordotic Spreader implants. Patients undergoing spinal procedures with this specific implant are most at risk.
Check for catalog number 5203-90137 and lot number FKXG on the product label. The product is a stainless steel, non-sterile interbody spacer system used for spinal procedures.
Look for catalog number 5203-90137 and lot number FKXG 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 spinal procedures.
The recall record does not specify a remedy, so contact K2M directly for instructions.
Check for catalog number 5203-90137 and lot number FKXG 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-2018-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2018-2020 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.
