K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal surgery procedures. Affected models include specific catalog numbers 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 spinal implants because the spreader tip can break during surgery. This poses a risk of complications during spinal procedures.
The spreader tip can break off during spinal surgery procedures, potentially causing complications for patients. This breakage occurs because the two pieces were welded together without sufficient strength during manufacturing.
Surgical teams using the recalled Aleutian Anatomically Narrow Lordotic Spreader systems for spinal procedures are most at risk. Patients undergoing spinal surgery with these specific implants may face complications.
Check for the catalog number 5203-90113 and lot number FKWY on the product. The product is a stainless steel, non-sterile interbody spacer system used in spinal procedures.
Look for catalog number 5203-90113 and lot number FKWY 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 spinal surgery procedures.
The recall record does not specify a remedy or action steps for affected products.
The recall indicates a risk of spreader tip breaking during surgery, so it is not safe to use without checking the recall status.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2011-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2011-2020 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.
