Z-2211-2013Class II

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

Name: Z-2211-2013 Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct...
Creator: Implantech Associates Inc
Published: 2013-08-30
License: https://open.fda.gov/license/

Implantech Associates Inc / initiated 2013-08-30 / Terminated / root cause: manufacturing process

FDA source

Implantech Associates Inc began a recall of Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region on 2013-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2211-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Posted: 2013-09-17
Terminated: 2014-02-06
Recalling firm: Implantech Associates Inc
Product: Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
Product code: FWP Prosthesis, Chin, Internal
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Catalog Number: TSCII-M Lot Numbers: 848488 and 850156

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2211-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2211-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17

Product code FWP

K902824Class IIExtended Chin Implant Style IImplantech Associates, Inc. / cleared 1990-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)