Recall Z-2211-2013— Implantech Associates Inc

Name: FDA recall Z-2211-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-30

Class II · Terminated

Class II FDA medical device recall by Implantech Associates Inc, initiated 2013-08-30, terminated 2014-02-06. It names one FDA 510(k) clearance: K902824. Product: Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.. Reason: 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..

Recalling firm: Implantech Associates Inc
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Terminated: 2014-02-06
Firm location: Ventura, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K902824 — EXTENDED CHIN IMPLANT STYLE IImplantech Associates, Inc.·cleared 1990-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.