Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tens
FDA device recall Z-0353-2014 · posted 2013-11-18 · Terminated
Recall details
- Recalling firm
- Restoration Robotics
- Reason for recall
- Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
- Action taken
- Restoration Robotics sent an Urgent Recall letters dated October 13, 2013 to all distributors via first class mail. Direct accounts were notified by phone as well as fax. Customers were informed of the affected product, problem and actions to be taken. Replacement products are being distributed to each site and will be delivered to each customer. For questions call 408-883-6760
- Root cause
- Process control
- Status
- Terminated
- Product code
- ONA
- Quantity affected
- 515 in US. 315 International.(included all packaging configurations)
- Distribution
- Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
- Date initiated
- 2013-10-13
- Date posted
- 2013-11-18
- Date terminated
- 2013-12-10
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE ARTAS SYSTEM (K123548) | Restoration Robotics, Inc. | 2013-02-25 |