K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal surgery procedures. Affected units have 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 certain Aleutian Anatomically Narrow Lordotic Spreader systems because the spreader tip can break during spinal surgery. This poses a risk of the broken piece causing injury to the patient during the procedure.
The spreader tip can break during spinal surgery procedures, potentially causing injury to the patient. This breakage occurs because the device was manufactured as two pieces welded together, which has been associated with the tip detaching.
Surgical teams using the recalled Aleutian Anatomically Narrow Lordotic Spreader systems for spinal procedures are affected. Patients undergoing spinal surgery with this specific device are at risk of injury from broken components.
Check for the product name 'Aleutian Anatomically Narrow Lordotic Spreader', stainless steel, non-sterile, quantity 1. Look for catalog number 5203-90135 and lot number FKXF.
Immediately stop using the recalled Aleutian Anatomically Narrow Lordotic Spreader systems if you have them in your surgical procedures.
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 surgery procedures.
Check for catalog number 5203-90135 and lot number FKXF on the device.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2017-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2017-2020 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.
