Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
FDA device recall Z-1037-2008 · posted 2008-04-30 · Terminated
Recall details
- Recalling firm
- Straumann Usa, Llc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- EGG
- Quantity affected
- 26 units
- Distribution
- Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX.
- Date initiated
- 2008-01-10
- Date posted
- 2008-04-30
- Date terminated
- 2009-11-06
- 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 |
|---|---|---|
| P.004 HEALING ABUTMENTS AND CLOSURE SCREWS (K071585) | Straumann USA | 2007-07-11 |