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

Recalled April 18, 2018 · FDA recall Z-1364-2018 · Orthofix

Hazard
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. · FDA Class II
Units
188 units
Sold at
US

Description

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.

Product
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
Manufacturer(s)
Orthofix, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

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