K2M recalls Aleutian Interbody Spacer Systems due to risk of spreader tip breaking off during spinal procedures. Affected units include specific model and lot numbers. Consumers should 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 Interbody Spacer Systems because the spreader tip can break off during spinal procedures. This poses a risk of injury to patients during surgery. Affected units have specific model numbers and lot codes.
The spreader tip can break off during spinal procedures, potentially causing injury to the patient. This breakage occurs because the device was manufactured as two pieces welded together, which may not hold securely under surgical stress.
Patients undergoing spinal procedures who received the Aleutian Interbody Spacer Systems with the specified model and lot numbers are most at risk. Medical professionals using these devices for surgical planning may also be affected.
Check for the model number 5203-90165 and lot number FKXR on the device. The product is a stainless steel, non-sterile interbody spacer system used for spinal procedures.
Reach out to K2M directly for specific instructions on how to report the device and get further assistance.
Yes, this device is used to simulate spine cage height and expand disc space during surgical planning.
The model number is 5203-90165.
Check for the model number 5203-90165 and lot number FKXR on the device.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2026-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2026-2020 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.
