Device Name: Terino Square Chin-Style II-Medium recallZ-2211-2013 · Implantech Associates Inc · initiated Aug 30, 2013
Class II Terminated All recalls posted in September 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Implantech Associates Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2211-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 30, 2013
- Posted by the FDA
- Sep 17, 2013
- Recalling firm
- Implantech Associates Inc
- Quantity
- 8
- Product code
- FWP
- FDA submissions
- K902824
- Distribution
- Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
Product description
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
Code information (models, lots, serial numbers)
Catalog Number: TSCII-M Lot Numbers: 848488 and 850156
Other devices under the same FDA submission
2 devices cleared under K902824 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Terino Square Chin-Style II Size: X-LargeImplantech Associates, Inc. · Prosthesis, Chin, Internal1 report
- Terino Square Chin-Style I Size: MediumImplantech Associates, Inc. · Prosthesis, Chin, Internal1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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