Recall Z-1037-2008 ยท EGG Attachment, Precision, All
Straumann Usa, Llc
Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
| Date | Apr 30, 2008 (initiated Jan 10, 2008) |
| Status | Terminated |
| Reason | Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection. |
| Root cause | Mixed-up of materials/components |
| Action | Consignees were notified by telephone on 1/10/08 followed by an Urgent Device Recall letter on January 10, 2008. The letter instructs users to return any affected product to the firm along with a recall acknowledgement form. For additional information, contact 978-747-2514. |
| Quantity | 26 units |
| Distribution | Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071585 | P.004 HEALING ABUTMENTS AND CLOSURE SCREWS Straumann USA, Jul 11, 2007 |