K2M recalls Aleutian Interbody Spacer Systems with a risk of spreader tip breaking during spinal procedures. Affected units have specific catalog and lot numbers. Contact K2M for details.
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 due to a risk that the spreader tip may break during spinal surgery. This could lead to complications for patients needing spinal implants.
The spreader tip can break during spinal procedures, potentially causing complications like improper implant placement or additional surgical risks. This happens because the device is made of two welded pieces that may separate under stress.
Patients undergoing spinal surgery who use this specific spacer system are at risk. Medical professionals using the device during procedures may need to take extra care.
Check for catalog number 5203-90153 and lot number FKXL. The device is a stainless steel, non-sterile spacer used in spinal procedures.
Look for catalog number 5203-90153 and lot number FKXL on the product.
The Aleutian Anatomically Narrow Lordotic Spreader has been associated with the spreader tip breaking off during spinal procedures.
The recall record does not specify a remedy, so contact K2M directly for guidance.
The recall indicates a risk of the spreader tip breaking during procedures, so it is not recommended for use until the manufacturer provides further instructions.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2022-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2022-2020 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.
