Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308 Dental implants
FDA device recall Z-0117-2015 · posted 2014-10-23 · Terminated
Recall details
- Recalling firm
- Straumann USA, LLC
- Reason for recall
- Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
- Action taken
- Strauman notified consignees of this Field Corrective Action by letter dated September 19, 2014 and delivered via hand by Straumann Representative. Accounts are requested to return inventory. Contact (978) 747-2514 for assistance.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 6 units
- Distribution
- US Distribution in states of: FL and MA.
- Date initiated
- 2014-09-19
- Date posted
- 2014-10-23
- Date terminated
- 2015-03-13
- 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 BONE LEVEL TAPERED IMPLANT (K140878) | Straumann USA, LLC | 2014-08-20 |