Device product
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
Z-2211-2013
Product summary
- Event
- Event 66208
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-2211-2013
Official wording
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.
Code information: Catalog Number: TSCII-M Lot Numbers: 848488 and 850156
Distribution pattern: Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
Derived failure modes
-
Unknown
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.