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U.S. Department of Health and Human Services

Class 2 Device Recall Endotine Transbleph 3.5

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  Class 2 Device Recall Endotine Transbleph 3.5 see related information
Date Initiated by Firm May 06, 2016
Create Date July 27, 2016
Recall Status1 Terminated 3 on August 12, 2016
Recall Number Z-2294-2016
Recall Event ID 74222
510(K)Number K042796  
Product Classification Screw, fixation, bone - Product Code HWC
Product Endotine Transbleph 3.5 (CFD-080-0167)
Code Information Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373
Recalling Firm/
Manufacturer		 MicroAire Surgical Instruments, LLC
3590 Grand Forks Blvd
Charlottesville VA 22911-9006
For Additional Information Contact
434-975-8000
Manufacturer Reason
for Recall		 MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).
FDA Determined
Cause 2		 Labeling Change Control
Action The firm is sending recall letters to the customers who have received the Endotine Transbleph 3.5 (CFD-080-0167), lot #285373. Letters sent by UPS to expedite the delivery.
Quantity in Commerce 29
Distribution The product was distributed in the United States and Sweden
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 = HWC and Original Applicant = COAPT SYSTEMS, INC.
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