VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacr
FDA device recall Z-0955-2017 · posted 2017-01-06 · Terminated
Recall details
- Recalling firm
- Voco GmbH
- Reason for recall
- Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.
- Action taken
- Voco Gmbh notified consignees via email on/about November 3, 2016. The consignees were informed about the incorrect labeling and requested not to use this affected lot as well as to return it. They were also requested to pass this information to their customers
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KLE
- Quantity affected
- 50 units
- Distribution
- Nationwide Distribution to FL, IA, NH, PA, SC and TX
- Date initiated
- 2016-11-03
- Date posted
- 2017-01-06
- Date terminated
- 2017-08-23
- Location
- Cuxhaven, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUTURABOND M+ (K141610) | Voco GmbH | 2014-08-01 |