Device recall
Z-0628-2014: REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA…
FDA device recall · Class II · Materialise USA LLC
Key facts
| Recall number (Z-number) | Z-0628-2014 |
|---|---|
| Recall event | 67039 |
| Product | REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are… |
| Product code | HRY |
| Recalling firm | Materialise USA LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 14, 2014 |
| 510(k) numbers | K110415 |
| FEI number | 3005718816 |
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