K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of tip breaking during spinal procedures. Affected units have specific catalog and lot numbers. Contact for return instructions.
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 spinal surgery tools because the spreader tip can break during procedures. This could lead to complications for patients needing spinal implants.
The spreader tip can break during spinal surgery procedures. This breakage may cause complications for patients requiring spinal implants.
Surgical teams using the Aleutian Anatomically Narrow Lordotic Spreader for spinal procedures are affected. Patients scheduled for spinal implant surgery using this device are at risk.
Check for catalog number 5203-90123 and lot number FKXC on the device. The product is a stainless steel, non-sterile spacer used in spinal procedures.
Look for catalog number 5203-90123 and lot number FKXC on the device.
The product has been associated with spreader tip breaking during procedures, so it should not be used until the recall is addressed.
The recall record does not specify a remedy, so contact K2M directly for instructions.
Check for catalog number 5203-90123 and lot number FKXC on the device.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2014-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2014-2020 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.
