K2M recalls Chesapeake Cervical-Ti 10mm Drill Guide Inserter due to risk of spinal cord injury from improper implant seating. Affected units have catalog number 3608-90033 and lot number MNAJ.
Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies
K2M recalls its Chesapeake Cervical-Ti 10mm Drill Guide Inserter for spinal surgery. If the implant doesn't seat properly, screws could misalign with vertebrae, risking spinal cord injury.
The 10mm Drill Guide Inserter may not mate flush with the inner shaft, causing splaying of the collet. This could lead to the implant falling into the spinal cord or screws misaligning with vertebrae, potentially causing spinal cord injury.
Surgical teams using the Chesapeake Cervical-Ti 10mm Drill Guide Inserter for spinal procedures. Patients receiving spinal surgery with this device are at risk if the implant doesn't seat correctly.
Check for catalog number 3608-90033 and lot number MNAJ on the device. This product is used in cervical spine surgeries and sold with specific identifiers.
Look for catalog number 3608-90033 and lot number MNAJ on the Chesapeake Cervical-Ti 10mm Drill Guide Inserter.
The 10mm Drill Guide Inserter may not mate flush with the inner shaft, causing splaying of the collet. This could lead to the implant falling into the spinal cord or screws misaligning with vertebrae, potentially causing spinal cord injury.
Check for catalog number 3608-90033 and lot number MNAJ on the device.
The recall does not specify a remedy, so contact K2M directly for guidance.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-1410-2021 — K2M K2M Hello, I own a K2M that is covered by recall Z-1410-2021 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.
