ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Check against the official notice below — it lists the full affected range.
Orthofix is voluntarily recalling Connector System set screws due to manufacturing defects affecting the drive feature. The recall includes Large Set Screws (PN: 79-2002) in Lot Numbers 001 and 002, and Small Set Screws (PN: 79-2003) in Lot Numbers 002, 003, and 004. The size discrepancies in the drive feature may prevent the Set Screw Driver (PN: 79-1006) from properly engaging with the screw, or the driver may become wedged in the corners of the drive feature, potentially resulting in a stripped set screw. A total of 397 units were distributed in the US.
The recall record does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Quantity: 397 units Lot/code info: UDI 18257200125371, Lot Numbers: O02, O03 and O04
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.