Smith & Nephew recalls TwinFix Ti 2.8 mm HS Suture Anchor due to potential sterile barrier breach from protective tube dislodging, risking device contamination.
Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.
Smith & Nephew is recalling TwinFix Ti 2.8 mm HS Suture Anchors because a protective tube may detach inside the pouch, risking contamination. This could lead to infections or other complications during medical procedures.
The protective tube can come off inside the pouch, allowing the device's pointed end to puncture the packaging. This could breach the sterile barrier, potentially contaminating the device and increasing infection risks during surgery.
Medical professionals using the TwinFix Ti 2.8 mm HS Suture Anchors for soft tissue fixation are most at risk. Patients receiving these devices during surgery may also be affected.
Check for batch numbers: 2010547, 2025137, 2036695, 50763859, or 50773071. The product is a TwinFix Ti 2.8 mm HS Suture Anchor with part number 72200796.
Inspect the protective tube for detachment inside the pouch; if it has come off, the device may be contaminated.
The recall indicates a potential risk of sterile barrier breach, so it is not recommended for use until the issue is resolved.
Check the batch numbers listed in the recall notice to see if your device is affected. If it is, stop using it and contact Smith & Nephew for guidance.
Look for batch numbers 2010547, 2025137, 2036695, 50763859, or 50773071 on the packaging or documentation.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1273-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1273-2020 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.
