FDAClass IISeptember 26, 2018

Gentle Thread PLGA Full Thread Interference Screw recall

Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629

Why was Gentle Thread PLGA Full Thread Interference Screw recalled?

The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.

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 Number 625450, UDI (1)00880304421066(17)221019(10)625450

Product
Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
Recalling firm
Zimmer Biomet, Inc.
Quantity
52
Distribution
The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Recall date
September 26, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls