FDAClass IIJune 12, 2019

Rim Plate recall

Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony…

Why was Rim Plate recalled?

The titanium implant has the wrong article number laser marked on it.

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?

Model Number: 21206-10; Lot Code: 26/F42778

Product
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony…
Recalling firm
I.T.S. GmbH
Quantity
65 devices
Distribution
Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.
Recall date
June 12, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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