FDAClass IIOctober 17, 2018

OrthoSensor VERASENSE for Zimmer Biomet Persona CR recall

OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.

Why was OrthoSensor VERASENSE for Zimmer Biomet Persona CR recalled?

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

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 numbers 20598 and 20607, UDI 00816818021423.

Product
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
Recalling firm
Orthosensor, Inc.
Quantity
36 devices
Distribution
Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
Recall date
October 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls