Integra recalls 9 1/4 inch GEMINI CLAMP for possible corrosion after multiple sterilizations, requiring replacement to prevent breakage during medical procedures.
A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument
Integra is recalling its 9 1:4 inch GEMINI CLAMP used in vascular procedures due to a crack risk after repeated cleaning that could cause breakage. This affects medical devices used in surgeries and requires replacement to avoid instrument failure.
Repeated cleaning and sterilization cycles can cause a small crack at the box lock corner. This crack may lead to corrosion, weakening the clamp and causing premature breakage during medical procedures.
Healthcare professionals using the clamp during vascular or cardiothoracic procedures. Patients at risk if the clamp breaks during surgery.
Check for the model 'Jarit GEMINI CLAMP 9 1/4 inch' with catalog number 140-332 and lot number AA1901. The product is used in vascular and cardiothoracic surgeries.
Look for the model name 'Jarit GEMINI CLAMP 9 1/4 inch' with catalog number 140-332 and lot number AA1901.
The recall is due to a small crack at the box lock corner that may weaken the instrument after multiple cleaning and sterilization cycles, potentially causing breakage.
The official recall does not provide a fix; the remedy is not stated in the record.
Check for the model 'Jarit GEMINI CLAMP 9 1/4 inch' with catalog number 140-332 and lot number AA1901.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-2435-2019 — Integra Integra Hello, I own a Integra that is covered by recall Z-2435-2019 from Integra. 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.
