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Terminated

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.

FDA Recall Z-0623-2014 · Posted 2014-01-03

Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeGET
Date Initiated2013-12-09
Date Terminated2014-12-02
Product Quantity14

Reason for Recall

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

Firm Action

Aesculap sent an Important Correction & Removal Notification letter dated December 9, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all affected product and returned to AIC (USA). Customers were instructed that a Aesculap Sales Representative would contact them to schedule return of any affected inventory and replace their product. Customers were asked to complete the inventory sheet with the quantity being returned. If customers could not locate the product, they were to provide an explanation as to why the inventory would not be returned (discarded, etc.). Customers with questions were instructed to call 610-984-9414, For questions regarding this recall call 800-258-1946, ext 5067.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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