FDA recall Z-1364-2018

Product

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

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

Key facts

Status

Terminated

Initiation date

2018-02-23

Report date

2018-04-18

Termination date

2019-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lewisville, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1364-2018