K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal procedures. Affected units include specific catalog numbers 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 Anatomically Narrow Lordotic Spreader systems because the spreader tip can break during spinal surgery. This poses a risk of complications for patients needing spinal procedures.
The spreader tip can break during spinal procedures, potentially causing complications for patients. This occurs because the two pieces are welded together and may separate under stress during surgery.
Patients undergoing spinal procedures who use the recalled Aleutian Anatomically Narrow Lordotic Spreader systems are at risk. Medical professionals using the specific model for spinal simulations may also be affected.
Check for catalog number 5203-90109 and lot number FKWW on the product. The product is a stainless steel, non-sterile spacer used to simulate spinal cage height.
Look for catalog number 5203-90109 and lot number FKWW on the product label.
Yes, the Aleutian Anatomically Narrow Lordotic Spreader is used to simulate spinal cage height during procedures to determine optimal implant size.
The recall record does not specify a remedy, so contact K2M directly for guidance.
Check for catalog number 5203-90109 and lot number FKWW on the product label.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-2009-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2009-2020 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.
