Orthofix, Inc: Medical Device Recall in 2018 - (Recall #: Z-1364-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002

Product Classification:

Class II

Date Initiated: February 23, 2018

Date Posted: April 18, 2018

Recall Number: Z-1364-2018

Event ID: 79498

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.

Status: Terminated

Product Quantity: 188 units

Code Information:

UDI 18257200125364, Lot Numbers: O01 and O02

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated