K2M recalls Aleutian Interbody Spacer Systems due to risk of spreader tip breaking during spinal surgery, potentially causing complications. Affected units include specific model 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 Interbody Spacer Systems after reports of the spreader tip breaking during spinal procedures. This could lead to complications for patients needing spinal surgery.
The spreader tip can break off during spinal surgery procedures. This breakage may cause complications such as improper implant placement or additional surgical intervention.
Patients scheduled for spinal surgery who use this specific model of interbody spacer system are affected. Surgeons and medical teams using the recalled product are at highest risk.
Check for the model name 'Aleutian Anatomically Narrow Lordotic Spreader', size 28x4mm, and lot number FKXJ. The product was sold with catalog number 5203-90149 and UDI number 10888857108622.
Verify the model name, size, lot number, and catalog number to confirm if your product is affected.
The product has been associated with the spreader tip breaking off during procedures, so it is not safe to use without recalling it.
The recall record does not specify a remedy, so contact K2M directly for guidance.
Check for the model name 'Aleutian Anatomically Narrow Lordotic Spreader', size 28x4mm, and lot number FKXJ.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2020-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2020-2020 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.
