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Recall

Class II — Aesculap, Inc.

Recalling firmAESCULAP, INC.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonCertain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.
ProductAesculap 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.
Quantity14
DistributionWorldwide 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.
Initiated2013-12-09
Classified2014-01-03
Terminated2014-12-02
Recall numberZ-0623-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Aesculap, Inc. (Z-0623-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67050/

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