5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece
FDA device recall Z-1884-2017 · posted 2017-04-27 · Terminated
Recall details
- Recalling firm
- XTANT MEDICAL INC
- Reason for recall
- The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.
- Action taken
- XTANT sent an Urgent Medical Device Removal letter dated 4/12/2017 to customers with a Return Response Acknowledgement and Receipt form. The letter identified the affected product, problem and actions to be taken. For questions call 406-570-7028.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MNH
- Quantity affected
- 97 units
- Distribution
- Worldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of Mexico.
- Date initiated
- 2017-04-12
- Date posted
- 2017-04-27
- Date terminated
- 2017-08-16
- Location
- Belgrade, MT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
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|---|---|---|
| FORTEX PEDICLE SCREW SYSTEM (K120832) | X-Spine Systems, Inc. | 2012-10-23 |