Orthofix recalls Connector System Large Set Screws (Lot 001-002) due to potential drive feature size discrepancies causing improper fitting with drivers.
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 large and small set screws from specific production lots because they may not fit properly with their drivers, risking stripped screws. This could cause damage to the connector system during installation.
The set screws have size discrepancies in their drive feature, which may not accept the recommended driver or could cause the driver to get wedged. This wedging might strip the screw, leading to improper installation of orthopedic hardware.
Users of Orthofix connector systems who purchased the recalled large set screws (Lot 001-002) or small set screws (Lot 002-004) are affected. Those installing these screws into orthopedic hardware systems face the highest risk.
Check for the product name 'Orthofix Connector System' with large set screw (Lot 001-002) or small set screw (Lot 002-004) on the packaging or label.
Look for lot numbers 001-002 on large set screws or 002-004 on small set screws to identify affected units.
The set screws have size discrepancies in their drive feature that may cause improper fitting with the driver, potentially leading to stripped screws.
Check the lot numbers on the packaging; if they match the recalled lots, contact Orthofix for guidance.
The recall record does not mention a remedy or fix for the set screws.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-1364-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-1364-2018 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.
