Date Initiated by Firm |
August 30, 2013 |
Date Posted |
September 17, 2013 |
Recall Status1 |
Terminated 3 on February 06, 2014 |
Recall Number |
Z-2211-2013 |
Recall Event ID |
66208 |
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 CA 93003-7602
|
For Additional Information Contact |
805-339-9415
|
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 |
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 |
Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel. |
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.
|
510(K) Database |
510(K)s with Product Code = FWP and Original Applicant = IMPLANTECH ASSOCIATES, INC.
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