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U.S. Department of Health and Human Services

Class 2 Device Recall Terino Square chinStyle IIMedium

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 Class 2 Recall
Terino Square chinStyle IIMedium
see related information
Date Posted September 17, 2013
Recall Status1 Terminated on February 06, 2014
Recall Number Z-2211-2013
Recall Event ID 66208
Premarket Notification
510(K) Number
K902824 
Product Classification Prosthesis, Chin, Internal - Product Code FWP
Product Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
Code Information Catalog Number: TSCII-M Lot Numbers: 848488 and 850156
Recalling Firm/
Manufacturer
Implantech Associates Inc
6025 Nicolle St Ste A
Ventura, California 93003-7602
Manufacturer Reason
for Recall
Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Recall was initiated by sending recall notification letters to customers on 08/30/2013 via a combination of 1st class mail, email, and telephone. The recall notification letter, dated August 30, 2013, informs customers of the reason for recall, product description and codes, instructions on what to do with the recalled product and contact information. Within the recall notification letter, a section is provided for responses and signatures.
Quantity in Commerce 8
Distribution Distributed in the states of NY, KY, and CO, and the country of Israel.
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.
510(K) Database 510(K)s with Product Code = FWP and Original Applicant = IMPLANTECH ASSOCIATES, INC.
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