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 for return instructions.
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 Interbody Spacer Systems because the spreader tip can break during spinal surgery. This poses a risk of complications for patients needing spinal procedures.
The spreader tip can break during spinal surgery procedures, potentially causing complications for patients. This happens because the device is manufactured as two pieces welded together, which may fail under stress during use.
Patients scheduled for spinal surgery using the recalled Aleutian Anatomically Narrow Lordotic Spreader systems are most at risk. Medical professionals using these devices for spinal procedures may also be affected.
Check for catalog number 5203-90157 and lot number FKXN on the device packaging. The device is a stainless steel, non-sterile interbody spacer system used in spinal procedures.
Look for catalog number 5203-90157 and lot number FKXN on the device packaging.
Yes, this device is used to simulate spine cage height and expand disc space during spinal procedures.
The recall record does not specify a remedy, so contact K2M directly for instructions.
Check for catalog number 5203-90157 and lot number FKXN on the device packaging.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2024-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2024-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
