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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 66208
Product Type Devices
Status Ongoing
Recalling Firm Implantech Associates Inc
City Ventura
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region. Catalog Number: TSCII-M Lot Numbers: 848488 and 850156 Class II 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. 8 Z-2211-2013