FDAClass IISeptember 30, 2015

Contra-Angles CA1:1L EVO 15 recall

Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

Why was Contra-Angles CA1:1L EVO 15 recalled?

Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

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?

Catalog numbers: 1600939-001 and 1600938-001 Serial numbers concerned: - Ref: 1600939-001: Serial numbers included in the following range: 15B0001 up to 15F0011 - Ref: 1600938-001: Serial numbers included in the following range: 15B0007 up to 15F0027

Product
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
Recalling firm
Bien Air Dental SA
Quantity
112 (U.S.)
Distribution
Worldwide Distribution - US distribution to one distributor in FL.
Recall date
September 30, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls