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Class 2 Device Recall Apple Medical Corporation |
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Date Initiated by Firm |
March 10, 2006 |
Date Posted |
April 06, 2006 |
Recall Status1 |
Terminated 3 on March 07, 2016 |
Recall Number |
Z-0617-06 |
Recall Event ID |
34810 |
510(K)Number |
K961460
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Product Classification |
Electrocautery, Gynecologic (And Accessories) - Product Code HGI
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Product |
Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154 |
Code Information |
Lot Numbers: D201709, D201707, D205003, A2004, D211319, D225404, D233020, C143G, D307909, D310619, D316306, H213C, I153A, J283B, L043C, A134C, A304 |
Recalling Firm/ Manufacturer |
Apple Medical Corporation 28 Lord Rd Ste 135 Marlborough MA 01752-4549
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For Additional Information Contact |
John C. Pulford 508-624-4645
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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.
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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 |
1,232.0 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
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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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510(K) Database |
510(K)s with Product Code = HGI and Original Applicant = APPLE MEDICAL CORP.
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