K2M recalls Aleutian Interbody Spacer Systems due to risk of spreader tip breaking off during spinal procedures. Affected units include specific model 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 Aleutian Interbody Spacer Systems because the spreader tip can break off during spinal procedures. This poses a risk of complications for patients undergoing surgery.
The spreader tip can break off during spinal procedures, potentially causing complications for patients. This occurs because the two pieces were welded together without proper strength.
Patients scheduled for spinal surgery using the recalled Aleutian Interbody Spacer Systems are most at risk. Healthcare providers using the specific model and lot numbers should check if their patients are affected.
Check for the model name 'Aleutian Interbody Spacer Systems', catalog number 5203-90125, and lot number FKXD. The product is used to simulate spine disc height during surgery.
Identify the catalog number 5203-90125 and lot number FKXD to confirm if your item is affected.
The product is not safe for use as it has been associated with spreader tip breaking off during procedures.
Check for catalog number 5203-90125 and lot number FKXD on the product label.
The recall record does not specify a remedy, so contact K2M directly for 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-2015-2020 — K2M K2M Hello, I own a K2M that is covered by recall Z-2015-2020 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.
