Z-1363-2018Class II

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

Name: Z-1363-2018 ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Creator: Orthofix, Inc
Published: 2018-02-23
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2018-02-23 / Terminated / root cause: manufacturing process

FDA source

Orthofix, Inc began a recall of ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 on 2018-02-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1363-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Posted: 2018-04-11
Terminated: 2019-06-18
Recalling firm: Orthofix SRL
Product: ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Product code: NKG Posterior Cervical Screw System
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm disseminated the recall notices on 02/23/2018 by mail. The firm requested the return of the screws.
Quantity in commerce: 397 units
Distribution: US
Product codes and lots: UDI 18257200125371, Lot Numbers: O02, O03 and O04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1363-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1363-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-11
Z-1364-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-11

Product code NKG

K172194Class IIConnector SystemOrthofix, Inc. / cleared 2017-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)