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Class 2 Device Recall Aesculap HiLine XXS handpiece |
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Date Initiated by Firm |
December 09, 2013 |
Date Posted |
January 03, 2014 |
Recall Status1 |
Terminated 3 on December 02, 2014 |
Recall Number |
Z-0623-2014 |
Recall Event ID |
67050 |
Product Classification |
Motor, surgical instrument, pneumatic powered - Product Code GET
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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 PA 18034-8217
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For Additional Information Contact |
Customer Support 800-258-1946 Ext. 5067
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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