FDAClass IIJanuary 15, 2014

Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces recall

Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.

Why was Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces recalled?

Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.

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?

Hi-Line XXS handpiece; Part Number - GB790R , Lot Number 4504385018 4504300008 4504328565 4504685847 4804685865

Product
Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.
Recalling firm
Aesculap, Inc.
Quantity
14
Distribution
Worldwide Distribution - USA including TX, NY, PA, and TN. Internationally to Austria, Switzerland, Germany, Denmark, Spain, Finland, France, Hong Kong, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, and Taiwan.
Recall date
January 15, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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