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.
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.
The spreader tip can break off during spinal procedures, potentially causing injury to the patient. This occurs because the two pieces are welded together and may separate under stress during surgery.
Patients undergoing spinal surgery who use the recalled Aleutian Interbody Spacer Systems are at risk. Medical professionals using the specific model for procedure simulation are most affected.
Check for the model name 'Aleutian Interbody Spacer Systems', catalog number 5203-90107, and lot number FKWV. The product is used to simulate spinal cage height during surgery.
Verify the catalog number 5203-90107 and lot number FKWV 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 with K2M directly for guidance.
The product is not safe for use as it has been associated with spreader tip breaking off during procedures.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2008-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2008-2020 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.
