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Recall

Class II — Implantech Associates Inc

Recalling firmIMPLANTECH ASSOCIATES, INC.
Registered facilityIMPLANTECH ASSOCIATES, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonImplantech 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.
ProductDevice Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
Quantity8
DistributionWorldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
Initiated2013-08-30
Classified2013-09-17
Terminated2014-02-06
Recall numberZ-2211-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Implantech Associates Inc (Z-2211-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66208/

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