CLASS II ONGOING Device recall · Reported 22 Apr 2020 · FDA Enforcement Report

djosurgical Linear Neck Trials with Spring Sides, Standard recalled

Encore Medical is recalling djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, distributed in 7 states. The recall was initiated on 10 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.

Quantity recalled28 (14 REF S200635 and 14 S200636)

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-1692-2020
FDA event ID: 85211
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 10 Jul 2018
FDA classified: 10 Apr 2020
Reported: 22 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

10 Jul 2018	Recall initiated by company
10 Apr 2020	Classified by FDA	+640 days
22 Apr 2020	Published in enforcement report	+12 days

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

Reason for recall

The retaining ring on the neck trials has a potential to fail interoperatively.

Product as listed by the FDA

djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.

Where it was distributed

Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.

California Colorado Maryland Minnesota Ohio Texas Washington

Questions about this recall

Why was it recalled?

The retaining ring on the neck trials has a potential to fail interoperatively.

Which lots are affected?

All Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.

Where was it sold?

Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.

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 26 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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