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 replacement.
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 spacers because the device can break during procedures, potentially causing complications. This affects surgeons and hospitals using the specific model with catalog number 5203-90127.
The spacer is made of two welded pieces that can break during surgery, causing the tip to detach. This could lead to complications like improper spinal alignment or additional surgical intervention.
Surgeons and hospitals using the Aleutian Anatomically Narrow Lordotic Spreader for spinal procedures are affected. Patients receiving this specific implant during surgery are at risk if the device breaks.
Check for catalog number 5203-90127 and lot number FKXE on the device. The spacer is used in spinal procedures to simulate cage height and expand disc space.
Look for catalog number 5203-90127 and lot number FKXE on the spacer.
Yes, the spacer can break during surgery, potentially causing complications like improper spinal alignment.
Contact K2M directly to confirm if your device is affected and get instructions.
Check for catalog number 5203-90127 and lot number FKXE 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-2016-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2016-2020 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.
