Orthofix recalls small set screws with specific lot numbers due to potential drive feature issues that could cause stripped screws. Affected items may not fit properly with the included driver.
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
Orthofix is recalling small set screws with lot numbers 002, 003, and 004 because the drive feature might not accept the set screw driver or could get wedged, leading to stripped screws. This could cause the screws to become damaged and fail to function properly.
The drive feature in the set screw may not properly accept the set screw driver, or the driver could get stuck in the corners of the drive feature. This might cause the set screw to become stripped, meaning it no longer functions correctly.
Users of Orthofix connector systems with the specific small set screws (lot numbers 002, 003, and 004) are affected. Those using these screws in applications requiring precise mechanical connections are most at risk.
Check for the product name 'Orthofix Connector System Small Set Screw' with lot numbers 002, 003, or 004. The unique identifier (UDI) is 18257200125371.
Look for the lot numbers 002, 003, or 004 on the product.
The drive feature may not accept the set screw driver or could get wedged, leading to stripped screws.
The recall does not specify a remedy, so contact Orthofix directly for guidance.
Check for lot numbers 002, 003, or 004 on the product with the unique identifier 18257200125371.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-1363-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-1363-2018 from Orthofix. 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.
