K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal surgery 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 the procedure.
K2M is recalling certain Aleutian Interbody Spacer Systems because the spreader tip can break off during spinal surgery. This could lead to complications for patients needing spinal procedures.
The spreader tip can break off during spinal surgery procedures. This breakage could cause complications for patients, including potential injury or the need for additional surgery.
Patients who have been scheduled for spinal surgery using the recalled Aleutian Anatomically Narrow Lordotic Spreader systems are most at risk. Medical professionals using these systems for spinal procedures may also be affected.
Check for the product name 'Aleutian Anatomically Narrow Lordotic Spreader', stainless steel construction, and catalog number 5203-90111. The product was sold with lot number FKWX.
Verify the product name, catalog number 5203-90111, and lot number FKWX to confirm if your item is recalled.
The recall indicates a risk of spreader tip breaking during surgery, so it is not recommended for use until the remedy is implemented.
The recall does not specify a remedy, so contact K2M directly for guidance on next steps.
Look for the product name 'Aleutian Anatomically Narrow Lordotic Spreader', stainless steel construction, catalog number 5203-90111, and lot number FKWX.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2010-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2010-2020 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.
