Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental imp
FDA device recall Z-0174-2015 · posted 2014-11-06 · Terminated
Recall details
- Recalling firm
- Straumann USA, LLC
- Reason for recall
- Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
- Action taken
- Straumann USA sent a Field Corrective Action Notice letter dated September 24, 2014 and delivered via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Straumann is requesting the return of unused implants. Returns and Customer Confirmation form is to be returned. Contact firm 781-747- 2514.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 111 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2014-09-24
- Date posted
- 2014-11-06
- Date terminated
- 2017-06-26
- Location
- Andover, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM (K121131) | Straumann USA | 2012-06-06 |