OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
FDA device recall Z-1382-2017 · posted 2017-02-28 · Terminated
Recall details
- Recalling firm
- Matrix Surgical Holdings, LLC
- Reason for recall
- Mislabeling. The packaging labeled as left mandible contained a right mandible.
- Action taken
- Matrix Surgical sent an Urgent Product Recall e-mail dated January 26, 2017, to the foreign consignees. The distributors were instructed to return the product in inventory, and to conduct a sub-recall, if needed. For further questions, please call ( 404) 862-3794.
- Root cause
- Other
- Status
- Terminated
- Product code
- KKY
- Quantity affected
- 28
- Distribution
- Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
- Date initiated
- 2017-01-25
- Date posted
- 2017-02-28
- Date terminated
- 2017-05-24
- Location
- Atlanta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMNIPORE CUSTOMIZED SURGICAL IMPLANTS (K133046) | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2014-05-14 |
| OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES (K123908) | Matrix Surgical USA | 2013-07-31 |