Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product
FDA device recall Z-2161-2012 · posted 2012-08-08 · Terminated
Recall details
- Recalling firm
- Straumann USA, LLC
- Reason for recall
- Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2
- Action taken
- Straumann notiifed accounts by telephone on July 10, 2012 and follow-up Field Safety Correction Action letter dated July 11, 2012, via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to discontinue use of the affected product and follow the instruction provided until replacement is received. For questions call 978-747-2514.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 14 Distributed in US
- Distribution
- US Nationwide Distribution including the countries of FL, IN, LA, NY and TX.
- Date initiated
- 2012-07-11
- Date posted
- 2012-08-08
- Date terminated
- 2012-09-05
- 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 NC CARES TITANIUM AND CERAMIC ABUTMENTS (K081005) | Institut Straumann AG | 2008-05-02 |