Recall Z-0277-2008 ยท OAT Implant, Endosseous, Orthodontic
Straumann USA LLC
Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
| Date | Dec 4, 2007 (initiated Sep 28, 2007) |
| Status | Terminated |
| Reason | Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060062 | STRAUMANN ORTHOSYSTEM Institut Straumann AG, Feb 3, 2006 |