Smith & Nephew recalls surgical drill packs with one sleeve instead of two, risking improper bone tunnel drilling during rotator cuff repairs. Affected units include specific lot numbers from August 2023.
The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
Smith & Nephew is recalling surgical drill packs that contain only one sleeve instead of two. This means the device won't properly drill the second bone tunnel during rotator cuff repairs, potentially causing surgical errors.
The drill pack includes only one sleeve instead of two. During surgery, this causes the device to fail to create the second bone tunnel properly, which could lead to surgical errors or complications.
Surgical teams using the T-F1X0 RCG Drill Pac for rotator cuff repairs are most at risk. Patients undergoing these procedures with the affected product could face improper bone tunnel drilling.
Check for lot numbers 2042492 or 2049408 on the packaging. The product is sold for surgical arthroscopic rotator cuff repair procedures and was distributed starting August 28, 2023.
Look for lot numbers 2042492 or 2049408 on the packaging to identify affected units.
The T-Fix sterile package contains only one sleeve instead of two, which means the device won't perform as intended for the second bone tunnel during surgical procedures.
The recall record does not specify a remedy, so there is no action required beyond checking the lot number.
No, the product is not safe for use as intended because it lacks a second sleeve, which can cause improper bone tunnel drilling during surgery.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-2702-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2702-2020 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.
