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Recall Observatory FDA recall evidence

Device 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.

Z-0623-2014

December 09, 2013

Class II

Product summary

Firm
Aesculap, Inc.
Event
Event 67050
Status
Terminated
Classification
Class II
Quantity
14
Official record key
device-enforcement:Z-0623-2014

Official wording

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

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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