Recall Z-2211-2013 ยท FWP Prosthesis, Chin, Internal
Implantech Associates Inc
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
| Date | Sep 17, 2013 (initiated Aug 30, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902824 | EXTENDED CHIN IMPLANT STYLE I Implantech Associates, Inc., Aug 1, 1990 |