K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal surgery procedures. Affected units have specific catalog 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 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 Aleutian Anatomically Narrow Lordotic Spreader systems for spinal procedures are affected. Patients undergoing spinal surgery with this device are at risk of injury from a broken spreader tip.
Check for catalog number 5203-90179 and lot number FKXW on the device. The product is a stainless steel, non-sterile interbody spacer system used in spinal procedures.
Immediately stop using the Aleutian Anatomically Narrow Lordotic Spreader if it is part of the recalled product line.
The recalled device is the Aleutian Anatomically Narrow Lordotic Spreader, catalog number 5203-90179, lot number FKXW.
The device 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, so the device must be stopped from use immediately.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2030-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2030-2020 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.
