FDA Medical Device Recalls (openFDA)
Implantech Associates Inc: 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
- 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.
- Status
- Terminated
- Initiated
- 2013-08-30
- Posted
- 2013-09-17
- Terminated
- 2014-02-06
- 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.
- 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
- 8
- Distribution
- Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
- Lot, serial or model codes
- Catalog Number: TSCII-M Lot Numbers: 848488 and 850156
- 510(k) numbers
- K902824
- PMA numbers
- not on file
- Product code
- FWP
- Firm FEI
- 1000142697
- Firm city
- Ventura
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28