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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 Recall
Trigger Finger Blades
see related information
Date Posted March 08, 2013
Recall Status1 Terminated 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, Texas 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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