Device recall
Z-2948-2020: PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and…
FDA device recall · Class II · MicroPort Orthopedics Inc.
Key facts
| Recall number (Z-number) | Z-2948-2020 |
|---|---|
| Recall event | 86211 |
| Product | PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK… |
| Product code | LWJ |
| Recalling firm | MicroPort Orthopedics Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K003016, K091423, K100866 |
| FEI number | 3010536692 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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