Device recall
Z-0220-2015: LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization…
FDA device recall · Class II · Biomet Spine LLC.
Key facts
| Recall number (Z-number) | Z-0220-2015 |
|---|---|
| Recall event | 69615 |
| Product | LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal… |
| Product code | MAX |
| Recalling firm | Biomet Spine LLC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 7, 2015 |
| 510(k) numbers | K102738 |
| FEI number | 3012447612 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database