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U.S. Department of Health and Human Services

Class 2 Device Recall Apple Medical Corporation

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  Class 2 Device Recall Apple Medical Corporation see related information
Date Initiated by Firm March 10, 2006
Date Posted April 06, 2006
Recall Status1 Terminated 3 on March 07, 2016
Recall Number Z-0618-06
Recall Event ID 34810
510(K)Number K961460  
Product Classification Electrocautery, Gynecologic (And Accessories) - Product Code HGI
Product Fischer Cone Biopsy Excisor - Lg - Shallow
Model: 900-155
Code Information Lot Numbers:  D201710, A2005, D205004, D218913, D229701, D304806, D307910, D316307, H213D, J073C, L153Q, A134B
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 2
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 831.0 boxes
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 and Original Applicant = APPLE MEDICAL CORP.
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