K2M recalls Chesapeake Anterior Lumbar Removal Tools with possible missing pins that could dislodge during surgery, requiring extra procedures. Affected units include specific model numbers and lots.
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
K2M is recalling Chesapeake Anterior Lumbar (AL) Removal Tools that may have missing pins. If pins dislodge during surgery, they could require extra procedures to remove or fix the issue.
The tool may arrive with missing pins that can dislodge during surgery. If pins enter the surgical cavity, they may require intraoperative removal or revision surgery to address the issue.
Surgical teams using the Chesapeake AL Removal Tool for spinal procedures are most at risk. Patients undergoing spinal surgery with this specific tool model are affected.
Check for model number 2008-90068 and lots CCUNA, HYMJ, or KNCU. The tool is sold under K2M, Inc. as the Chesapeake Anterior Lumbar Removal Tool.
Inspect the tool for missing pins before use. If pins are missing, do not use the tool.
The tool may arrive with missing pins that could dislodge during surgery, requiring extra procedures like intraoperative removal or revision surgery.
Model number 2008-90068 and lots CCUNA, HYMJ, KNCU are affected.
No immediate stop is required, but check for missing pins before use. If pins are missing, do not use the tool.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-0104-2022 — K2M K2M Hello, I own a K2M that is covered by recall Z-0104-2022 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.
