Device recall
Z-1544-2012: PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~…
FDA device recall · Class II · Materialise USA LLC
Key facts
| Recall number (Z-number) | Z-1544-2012 |
|---|---|
| Recall event | 61699 |
| Product | PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument is intended to be used as a surgical instrument to assist in… |
| Product code | JWH |
| Recalling firm | Materialise USA LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2013 |
| 510(k) numbers | K111492 |
| 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