FDAFDA · Food and drugs·Recall number Z-2211-2013
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
Published September 25, 2013 · Recall initiated: August 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Implantech Associates Inc
- Distributor
- Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
- Lot
- Catalog Number: TSCII-M Lot Numbers: 848488 and 850156
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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