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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

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

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 Letter
Distribution Pattern Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
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