Device recall
Z-0418-2015: Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is…
FDA device recall · Class II · Materialise USA LLC
Key facts
| Recall number (Z-number) | Z-0418-2015 |
|---|---|
| Recall event | 69632 |
| Product | Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary… |
| Product code | JWH |
| Recalling firm | Materialise USA LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 17, 2015 |
| 510(k) numbers | K121640 |
| FEI number | 3005718816 |
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