Device recall
Z-0943-2017: PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort…
FDA device recall · Class II · MicroPort Orthopedics Inc.
Key facts
| Recall number (Z-number) | Z-0943-2017 |
|---|---|
| Recall event | 75888 |
| Product | PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This |
| Product code | LZO |
| Recalling firm | MicroPort Orthopedics Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2018 |
| 510(k) numbers | K012091 |
| FEI number | 3010536692 |
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