CLASS II Device recall · Reported 18 Apr 2018 · FDA Enforcement Report

Connector System, Large Set Screw recalled by Orthofix

Orthofix is recalling Orthofix, Connector System, Large Set Screw. The recall was initiated on 23 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 18257200125364, Lot Numbers: O01 and O02

Quantity recalled188 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1364-2018
FDA event ID: 79498
Recalling firm: Orthofix, Lewisville, TX
Classification: Class II
Status: Terminated
Recall initiated: 23 Feb 2018
FDA classified: 11 Apr 2018
Reported: 18 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

23 Feb 2018	Recall initiated by company
11 Apr 2018	Classified by FDA	+47 days
18 Apr 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

Where it was distributed

Questions about this recall

Is Connector System, Large Set Screw recalled?

Yes. Orthofix recalled Connector System, Large Set Screw on 23 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1364-2018.

Why was it recalled?

Which lots are affected?

UDI 18257200125364, Lot Numbers: O01 and O02

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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