Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is inten
FDA device recall Z-1876-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Straumann Manufacturing Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 129 units
- Distribution
- Class III Recall - Nationwide Distribution.
- Date initiated
- 2008-05-28
- Date posted
- 2008-09-16
- Date terminated
- 2009-11-06
- Location
- Andover, MA
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