Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or tr
FDA device recall Z-2211-2013 · posted 2013-09-17 · Terminated
Recall details
- Recalling firm
- Implantech Associates Inc
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FWP
- Quantity affected
- 8
- Distribution
- Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.
- Date initiated
- 2013-08-30
- Date posted
- 2013-09-17
- Date terminated
- 2014-02-06
- Location
- Ventura, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTENDED CHIN IMPLANT STYLE I (K902824) | Implantech Associates, Inc. | 1990-08-01 |