FDAClass IIJuly 27, 2016

Modified Linear Standard/lateral Neck Trials with recall

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

Why was Modified Linear Standard/lateral Neck Trials with recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

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

Product
MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
Recalling firm
Encore Medical, Lp
Quantity
14 (7 sets)
Distribution
CO, ID, TX
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls