Smith&Nephew recalls SmartStitch PerfectPasser Connector (REF # OM-8010) due to manufacturing error causing upper jaw to potentially disengage during use. Affected units have specific batch numbers.
The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.
Smith&Nephew is recalling its SmartStitch PerfectPasser Connector (REF # OM-8010) because a manufacturing error may cause the upper jaw to detach during use. This poses a risk of injury if the device becomes disengaged while in operation.
The recall is for a manufacturing error that results in incorrect upper jaw dimensions. This could cause the upper jaw to disengage or detach during use, potentially leading to injury if the device becomes loose or separates while being operated on.
Patients using prescription SmartStitch PerfectPasser Connectors for medical procedures are affected. Those with the specific batch numbers listed in the recall are most at risk.
Check the product's batch number on the connector, which is listed in the recall (e.g., 1154857, 1179855, etc.). The device is prescription-only and has a specific UDI code (00817470006971).
Look for the batch number on the connector, which is listed in the recall (e.g., 1154857, 1179855, etc.).
If the upper jaw disengages or detaches during use, stop using the device immediately and contact your healthcare provider.
The recall includes batch numbers: 1154857, 1179855, 1184077, 1194208, 2005153, and other specific numbers listed in the recall notice.
The device is safe to use if the upper jaw remains properly attached. However, if it disengages during use, stop using it immediately and contact your healthcare provider.
Check the batch number on the connector against the list provided in the recall notice (e.g., 1154857, 1179855, etc.). The device is prescription-only and has a specific UDI code (00817470006971).
We’ve drafted a message you can send Smith&Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-3000-2020 — Smith&Nephew Smith&Nephew Hello, I own a Smith&Nephew that is covered by recall Z-3000-2020 from Smith&Nephew. 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.
