Z-2211-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2013
- Initiation Date
- August 30, 2013
- Termination Date
- February 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
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.
Distribution Pattern
Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
Code Information
Catalog Number: TSCII-M Lot Numbers: 848488 and 850156