Recall Z-1364-2018— Orthofix, Inc

Name: FDA recall Z-1364-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-23

Class II · Terminated

Class II FDA medical device recall by Orthofix, Inc, initiated 2018-02-23, terminated 2019-06-18. It names one FDA 510(k) clearance: K172194. Product: ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002. Reason: 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..

Recalling firm: Orthofix, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Terminated: 2019-06-18
Firm location: Lewisville, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K172194 — Connector SystemOrthofix, Inc.·cleared 2017-08-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.