Recall Z-1876-2008 ยท DZE Implant, Endosseous, Root-Form
Straumann Manufacturing Inc.
Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants.
| Date | Sep 16, 2008 (initiated May 28, 2008) |
| Status | Terminated |
| Reason | Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device. |
| Root cause | Nonconforming Material/Component |
| Action | On May 28, 2008, Straumann issued an Urgent Device Recall and a Recall Acknowledgement Form to its consignees via Fed Ex. Accounts are requested to return product and a replacement or credit will issue. If you have any questions contact Bernie McDonald at (978) 747-2514. |
| Quantity | 129 units |
| Distribution | Class III Recall - Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.