CLASS II Device recall · Reported 12 Mar 2014 · FDA Enforcement Report

Variable Locking Screw This device is part of the Variable recalled

Synthes is recalling Synthes Variable Locking Screw This device is part of the Variable Angle Locking, distributed nationwide in the US. The recall was initiated on 5 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codespart no. 02.231.240, lot no. 823111

Quantity recalled45

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-1125-2014
FDA event ID: 67498
Recalling firm: Synthes, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 5 Feb 2014
FDA classified: 4 Mar 2014
Reported: 12 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

5 Feb 2014	Recall initiated by company
4 Mar 2014	Classified by FDA	+27 days
12 Mar 2014	Published in enforcement report	+8 days

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

Reason for recall

Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.

Where it was distributed

Nationwide Distribution including GA, CA, TX, MO, OH, PA, WA, AL, IN, AZ, MI, IA, TN, KY, NC, VA, NY, LA, IL, UT, and KS.

Nationwide Alabama Arizona California Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Michigan Missouri North Carolina New York Ohio Pennsylvania Tennessee Texas Utah Virginia

Questions about this recall

Is Variable Locking Screw This device is part of the Variable Angle Locking Compression recalled?

Yes. Synthes recalled Variable Locking Screw This device is part of the Variable Angle Locking Compression on 5 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1125-2014.

Why was it recalled?

Which lots are affected?

part no. 02.231.240, lot no. 823111

Where was it sold?

Nationwide Distribution including GA, CA, TX, MO, OH, PA, WA, AL, IN, AZ, MI, IA, TN, KY, NC, VA, NY, LA, IL, UT, and KS.

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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