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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap HiLine XXS handpiece

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 Class 2 Recall
Aesculap HiLine XXS handpiece
see related information
Date Posted January 03, 2014
Recall Status1 Terminated on December 02, 2014
Recall Number Z-0623-2014
Recall Event ID 67050
Product Classification Motor, Surgical Instrument, Pneumatic Powered - Product Code GET
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.
Code Information Hi-Line XXS handpiece; Part Number - GB790R , Lot Number 4504385018 4504300008 4504328565 4504685847 4804685865
Recalling Firm/
Manufacturer
Aesculap, Inc.
3773 Corporate Pkwy
Center Valley, Pennsylvania 18034-8217
For Additional Information Contact Customer Support
800-258-1946 Ext. 5067
Manufacturer Reason
for Recall
Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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