Orthofix, Inc recalls ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002

Recall date

February 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1364-2018

FDA classification

Class II

Brand / firm

Orthofix, Inc

Sold / distributed

US

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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