Integra LifeSciences recalls disposable cranial perforator kits with a potential weld issue that could cause disassembly. Affected models include specific lot numbers and UDI codes.
Inadequate weld that can potentially cause the product to disassemble.
Integra NeuroSciences is recalling disposable craniotomy kits that may have inadequate welds, which could cause the product to disassemble. This poses a risk of injury during surgical procedures.
The kit has a weld that may not hold properly, potentially causing parts to separate during surgical procedures. This could lead to injury if the disassembly occurs while the device is in use.
Surgical professionals using the recalled craniotomy kits are most at risk. Patients undergoing surgery with these kits could face complications if the product disassembles during use.
Check for model number 261230 and lot numbers listed in the recall notice. The unique device identifier (UDI) starts with 10381780513629.
Verify the model number (261230) and lot numbers from the recall list to confirm if your kit is affected.
Reach out to Integra NeuroSciences for guidance on next steps if your kit is confirmed affected.
The recall indicates a potential weld issue that could cause disassembly, so it is not safe to use without confirmation of the fix.
Check the model number and lot numbers against the recall list provided by Integra NeuroSciences.
Look for model number 261230 and lot numbers listed in the recall notice, including the UDI starting with 10381780513629.
We’ve drafted a message you can send Integra NeuroSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1717-2025 — Integra NeuroSciences Integra NeuroSciences Hello, I own a Integra NeuroSciences that is covered by recall Z-1717-2025 from Integra NeuroSciences. 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.
