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U.S. Department of Health and Human Services

Class 2 Device Recall Trigger Finger Blades

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  Class 2 Device Recall Trigger Finger Blades see related information
Date Initiated by Firm September 18, 2012
Date Posted March 08, 2013
Recall Status1 Terminated 3 on April 10, 2013
Recall Number Z-0922-2013
Recall Event ID 63551
Product Classification Accessories,arthroscopic - Product Code NBH
Product Endotrig Trigger Release Sterile Micro Hook Blade

Product Usage:
The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
Code Information Model number 1052; Lots M674180, MAKL170, M674200
Recalling Firm/
Manufacturer		 Instratek, Incorporated
4141 Directors Row
Ste. H
Houston TX 77092-8743
For Additional Information Contact Jeff Seavey
281-890-8020
Manufacturer Reason
for Recall		 Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm decided to recall the product and sent notification letters to consignees dated 09/18/2012.
Quantity in Commerce 235
Distribution USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.
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.
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