LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is
FDA device recall Z-0220-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Biomet Spine LLC.
- Reason for recall
- Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
- Action taken
- Biomet notified customers by phone on March 9, 2011 to return the affected product.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 120
- Distribution
- US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
- Date initiated
- 2011-03-09
- Date posted
- 2014-12-16
- Date terminated
- 2015-01-07
- Location
- Broomfield, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LANX FUSION SYSTEM (K102738) | Lanx, LLC | 2011-02-10 |