FDAClass IIApril 22, 2020

djosurgical Linear Neck Trials with Spring Sides recall

djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral…

Why was djosurgical Linear Neck Trials with Spring Sides recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral…
Recalling firm
Encore Medical, LP
Quantity
28 (14 REF S200635 and 14 S200636)
Distribution
Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.
Recall date
April 22, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls