FDAClass IIApril 4, 2018

PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 recall

PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid…

Why was PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 recalled?

A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.

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?

Item# 42-5320-067-02 Lot # 63236047

Product
PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid…
Recalling firm
Zimmer Biomet, Inc.
Quantity
3 units
Distribution
Non-USA Customer
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls