FDA-Device2018-04-18Class II

ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003

Orthofix, Inc
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.

Sold states
US
Affected count
397 units
Manufactured in
3451 Plano Pkwy, Lewisville, TX, United States
Products
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1363-2018

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