CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report

Modified Linear Standard/lateral Neck Trials With Spring Sides recalled

Encore Medical is recalling Modified Linear Standard/lateral Neck Trials With Spring Sides, distributed in Colorado, Idaho, Texas. The recall was initiated on 21 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901

Quantity recalled14 (7 sets)

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-2242-2016
FDA event ID: 74484
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Terminated
Recall initiated: 21 Jun 2016
FDA classified: 19 Jul 2016
Reported: 27 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

21 Jun 2016	Recall initiated by company
19 Jul 2016	Classified by FDA	+28 days
27 Jul 2016	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

Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

Where it was distributed

CO, ID, TX

Colorado Idaho Texas

Questions about this recall

Is Modified Linear Standard/lateral Neck Trials With Spring Sides recalled?

Yes. Encore Medical recalled Modified Linear Standard/lateral Neck Trials With Spring Sides on 21 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2242-2016.

Why was it recalled?

Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

Which lots are affected?

Lot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901

Where was it sold?

CO, ID, TX

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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