Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-
FDA device recall Z-0277-2008 · posted 2007-12-04 · Terminated
Recall details
- Recalling firm
- Straumann USA LLC
- Reason for recall
- Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
- Action taken
- Straumann USA, LLC sent Urgent Device Recall letters, via FedFx on 9/28/07, requesting the return of all Straumann Palatal Implant, articles 042.335 with lot numbers 1001, FE3776, F4662, F6563, E7083, and article 042.336S lot number 1001.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OAT
- Quantity affected
- 58 units
- Distribution
- Nationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA, and WA.
- Date initiated
- 2007-09-28
- Date posted
- 2007-12-04
- Date terminated
- 2010-04-16
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRAUMANN ORTHOSYSTEM (K060062) | Institut Straumann AG | 2006-02-03 |