Class 2 Device Recall Apple Medical Corporation

• Date Initiated by Firm: March 10, 2006
• Date Posted: April 06, 2006
• Recall Status: Terminated on March 07, 2016
• Recall Number: Z-0621-06
• Recall Event ID: 34810
• 510(K)Number: K961460
• Product Classification: Electrocautery, Gynecologic (And Accessories) - Product Code HGI
• Product: Fischer Cone Biopsy Excisor Model: 900-158
• Code Information: Lot Numbers: A2007, D205007
• Recalling Firm/ Manufacturer: Apple Medical Corporation; 28 Lord Rd Ste 135; Marlborough MA 01752-4549
• For Additional Information Contact: John C. Pulford; 508-624-4645
• Manufacturer Reason for Recall: Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
• FDA Determined Cause: Other
• Action: Apple Medical Corporation issued letters dated March 21, 2006 to direct accounts and distributors via US Mail. Distributors are requested to sub-recall. Product is to be returned to the firm and destroyed.
• Quantity in Commerce: 129.0 boxes (10 each)
• Distribution: Nationwide Foreign: Australia, Austria, Taiwan, England, FInland, Germany, Iceland, Israel, Italy, Portugal, Hong Kong, Spain, The Netherlands, Chile.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = HGI