Device recall
Z-1066-2014: Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R…
FDA device recall · Class II · Smith & Nephew Inc
Key facts
| Recall number (Z-number) | Z-1066-2014 |
|---|---|
| Recall event | 67404 |
| Product | Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures… |
| Product code | MBL |
| Recalling firm | Smith & Nephew Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 15, 2016 |
| 510(k) numbers | K960094 |
| FEI number | 1020279 |
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