Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cas
FDA device recall Z-2690-2014 · posted 2014-09-23 · Terminated
Recall details
- Recalling firm
- Justright Surgical, LLC
- Reason for recall
- JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.
- Action taken
- Consignees were notified via letter on August 27, 2014 in addition, the sales rep will hand deliver the Recall Notification on 8/28/14. Acknowledgement Form will be provided and returned products will be sent to STD Med where it will be held in quarantine.
- Root cause
- Process design
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 3 cases containing 18 units
- Distribution
- Distributed in the states of Colorado, California and New York.
- Date initiated
- 2014-08-27
- Date posted
- 2014-09-23
- Date terminated
- 2014-10-06
- Location
- Boulder, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD (K132472) | Justright Surgical, LLC | 2014-02-11 |